Traumatic Brain Injury Clinical Trial
Official title:
Transcranial Photobiomodulation to Improve Cognition in TBI, With Pre-/Post- fMRI Scans: A Pilot, Sham-Controlled Study
The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 years old - Must have had one (or more) closed-head, traumatic brain injuries - Loss of consciousness 24 hours or less; or no loss of consciousness/ A period of altered mental status (post-traumatic amnesia)/mental confusion for 24 hours or less - Must be able to come to VA Boston Healthcare System, Jamaica Plain Campus for testing visits and Boston University Center for Biomedical Imaging, Boston University School of Medicine for MRI scans Must meet the following Screening requirements: - Participants must score at least 2 SD below normal on at least 1 of the NP tests; or 1 SD below on at least 2 of these NP tests administer at Entry testing: Trail Making Test A & B; Controlled Oral Word Association Test (COWAT/FAS); California Verbal Learning Test II; DKEFS Color-Word Interference Test (Stroop). Exclusion Criteria: - Diagnosis of a neurological disease such amyotrophic lateral sclerosis (ALS), Parkinson's, Alzheimer's disease - History of craniotomy or craniectomy - A current life-threatening disease such as cancer - Disease requiring organ transplant - A severe mental disorder such as schizophrenia, bipolar disorder (not associated with clinically diagnosed PTSD) - Current substance abuse or active treatment; within the last 6 months - The Test of Memory Malingering is administered at screening; Participants must not have scores that indicate evidence of malingering, a score of less than 45 on either Part 1 or 2 would show evidence of malingering, with the following exception: If a participant fails Trial 1, but does not fail Trial 2, he/she would not be excluded if he/she also show evidence of poor learning on other NP Screening tests, such as the CVLT. If he/she fails Trial 2, alone, or Trial 1 and Trial 2, then this would exclude the participant from the study. - Self-reported pain questionnaires (VAS Pain Rating and the Short Form McGill Pain Questionnaire) are also administered. Participants may not have a level of pain greater than 7/10 on VAS or 38/50 on the McGill pain questionnaires at the time of screening. Exclusion for Magnetic Resonance Imaging Only - A BU MRI safety screening form will be reviewed at the time of study screening, as well as at each MRI scan appointment to ensure the participant can safely have an MRI. Participants must tell the investigator about any operations and any metal in his/her body, so it can be decided if it is safe for you to proceed with the scan. Participants cannot have a MRI scan: - if pregnant. - if he/she has pacemakers, ear implants, shrapnel injuries, or other types of metal or electric device in their body |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston VA Research Institute, Inc. | VA Boston Healthcare System, Vielight Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CVLT-II, Long Delay Free Recall 1 | California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.
Alternate lists are used at each testing timepoint to avoid practice effect |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Primary | CVLT-II, Long Delay Free Recall 2 | California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.
Alternate lists are used at each testing timepoint to avoid practice effect |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Primary | CVLT-II, Long Delay Free Recall 3 | California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.
Alternate lists are used at each testing timepoint to avoid practice effect |
Change from 1-Week to 1-Month after Series 1 | |
Primary | CVLT-II, Long Delay Free Recall 4 | California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.
Alternate lists are used at each testing timepoint to avoid practice effect |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | CVLT-II, Short Delay Free Recall 1 | California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | CVLT-II, Short Delay Free Recall 2 | California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | CVLT-II, Short Delay Free Recall 3 | California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | CVLT-II, Short Delay Free Recall 4 | California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | CVLT-II, Short Delay Cued Recall 1 | California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | CVLT-II, Short Delay Cued Recall 2 | California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | CVLT-II, Short Delay Cued Recall 3 | California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | CVLT-II, Short Delay Cued Recall 4 | California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | CVLT-II, Long Delay Cued Recall 1 | California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | CVLT-II, Long Delay Cued Recall 2 | California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | CVLT-II, Long Delay Cued Recall 3 | California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | CVLT-II, Long Delay Cued Recall 4 | California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | CVLT-II, Total Trials 1-5 _1 | California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | CVLT-II, Total Trials 1-5 _2 | California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | CVLT-II, Total Trials 1-5 _3 | California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | CVLT-II, Total Trials 1-5 _4 | California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 3 _1 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.
Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible. |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 3 _2 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.
Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible. |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 3 _3 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.
Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible. |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 3 _4 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.
Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible. |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 4 _1 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.
Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 4 _2 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.
Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 4 _3 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.
Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Color-Word Interference (Stroop) Test, Trial 4 _4 | Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.
Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 2) 1 | Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 2) 2 | Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 2) 3 | Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 2) 4 | Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 4) 1 | Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 4) 2 | Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 4) 3 | Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | Delis-Kaplan Executive Function Trails (Condition 4) 4 | Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Benton Visual Memory Test; Trial 1 Immediate Recall 1 | Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. Total possible 12 points |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Benton Visual Memory Test; Trial 1 Immediate Recall 2 | Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. Total possible 12 points |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Trial 1 Immediate Recall 3 | Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. Total possible 12 points |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Trial 1 Immediate Recall 4 | Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. Total possible 12 points |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Benton Visual Memory Test; Total Trials 1 | Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Benton Visual Memory Test; Total Trials 2 | Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Total Trials 3 | Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Total Trials 4 | Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.
Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Benton Visual Memory Test; Delayed Recall 1 | Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).
Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure. |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Benton Visual Memory Test; Delayed Recall 2 | Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).
Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure. |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Delayed Recall 3 | Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).
Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure. |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Benton Visual Memory Test; Delayed Recall 4 | Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).
Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure. |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Beck Depression Inventory (BDI) 1 | 21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Beck Depression Inventory (BDI) 2 | 21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Beck Depression Inventory (BDI) 3 | 21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | Beck Depression Inventory (BDI) 4 | 21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Post Traumatic Stress Disorder (PCL) 1 | 17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Post Traumatic Stress Disorder (PCL) 2 | 17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Post Traumatic Stress Disorder (PCL) 3 | 17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | Post Traumatic Stress Disorder (PCL) 4 | 17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Visual Analog Pain Rating Scale (VAS) 1 | Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10. | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Visual Analog Pain Rating Scale (VAS) 2 | Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10. | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Visual Analog Pain Rating Scale (VAS) 3 | Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10. | Change from 1-Week to 1-Month after Series 1 | |
Secondary | Visual Analog Pain Rating Scale (VAS) 4 | Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10. | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Short Form, McGill Pain Questionnaire 1 | Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).
Sum totaled for all categories |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Short Form, McGill Pain Questionnaire 2 | Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).
Sum totaled for all categories |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Short Form, McGill Pain Questionnaire 3 | Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).
Sum totaled for all categories |
Change from 1-Week to 1-Month after Series 1 | |
Secondary | Short Form, McGill Pain Questionnaire 4 | Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).
Sum totaled for all categories |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) 1 | 9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) 2 | 9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) 3 | 9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome | Change from 1-Week to 1-Month after Series | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) 4 | 9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Quality of Community Integration Questionnaire Total CIQ Score 1 | CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.
Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29 |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Total CIQ Score 2 | CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.
Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29 |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Total CIQ Score 3 | CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.
Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29 |
Change from 1-Week to 1-Month after Series | |
Secondary | Quality of Community Integration Questionnaire Total CIQ Score 4 | CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.
Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29 |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Quality of Community Integration Questionnaire (QCIQ) Score 1 | Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Quality of Community Integration Questionnaire (QCIQ) Score 2 | Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Quality of Community Integration Questionnaire (QCIQ) Score 3 | Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome | Change from 1-Week to 1-Month after Series | |
Secondary | Quality of Community Integration Questionnaire (QCIQ) Score 4 | Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Satisfaction Score 1 | Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24 | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Satisfaction Score 2 | Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24 | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Satisfaction Score 3 | Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24 | Change from 1-Week to 1-Month after Series | |
Secondary | Quality of Community Integration Questionnaire Cognitive Satisfaction Score 4 | Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24 | Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Quality of Life Score 1 | Cognitive Quality of Life Score:
Cognitive Satisfaction Score x score on item 16. Range: 6 - 72 |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Quality of Life Score 2 | Cognitive Quality of Life Score:
Cognitive Satisfaction Score x score on item 16. Range: 6 - 72 |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Quality of Community Integration Questionnaire Cognitive Quality of Life Score 3 | Cognitive Quality of Life Score:
Cognitive Satisfaction Score x score on item 16. Range: 6 - 72 |
Change from 1-Week to 1-Month after Series | |
Secondary | Quality of Community Integration Questionnaire Cognitive Quality of Life Score 4 | Cognitive Quality of Life Score:
Cognitive Satisfaction Score x score on item 16. Range: 6 - 72 |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Dysexecutive Functional Index (DEX) 1 | Self-Report of psychosocial problems that participant may be experiencing in everyday life.
20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome |
Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Dysexecutive Functional Index (DEX) 2 | Self-Report of psychosocial problems that participant may be experiencing in everyday life.
20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome |
Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Dysexecutive Functional Index (DEX) 3 | Self-Report of psychosocial problems that participant may be experiencing in everyday life.
20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome |
Change from 1-Week to 1-Month after Series | |
Secondary | Dysexecutive Functional Index (DEX) 4 | Self-Report of psychosocial problems that participant may be experiencing in everyday life.
20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome |
Change from Pre-Treatment Baseline to 1-Week after Series 2 | |
Secondary | Tinnitus Functional Index 1 | 25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress | Change from Pre-Treatment Baseline to 1-Week after Series 1 | |
Secondary | Tinnitus Functional Index 2 | 25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress | Change from Pre-Treatment Baseline to 1-Month after Series 1 | |
Secondary | Tinnitus Functional Index 3 | 25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress | Change from 1-Week to 1-Month after Series | |
Secondary | Tinnitus Functional Index 4 | 25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress | Change from Pre-Treatment Baseline to 1-Week after Series 2 |
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