Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)

Traumatic Brain Injury Clinical Trial

Official title:

Treatment of Word Finding Difficulties and Verbal Retrieval Deficits in Civilians Who Sustain a Chronic Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408975
• Other study ID #: STU-2022-0999
• Secondary ID: 1K99DC020185-015
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: The University of Texas at Dallas
• Contact: Hsueh-Sheng Chiang, MD, PhD
• Phone: 469-708-4925
• Email: hschiang[@]utdallas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-veteran) participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Description:

Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at 2-months follow-up testing sessions.

Civilians with histories of traumatic brain injuries and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline). Magnetic resonance imaging of the brain will be obtained only at the baseline assessment.

Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and one time following treatment competition (i.e., 2-months). For participants who complete the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment session 10 and one time following competition of the second treatment (i.e., 2-months).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria: Participants are to be between the ages of 18-85, are non-military personnel and not veterans, and have had a traumatic brain injury (more than a year ago prior to study participation) that has led to a complaint of word finding difficulty since the brain injury, confirmed to represent a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.

Exclusion Criteria:

• an implanted/electronic device, such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.).

• skull defects

• a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, post-traumatic stress disorder, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis.

• inability to give informed consent

• currently pregnant

• not a native English speaker

Related Conditions & MeSH terms

• Acquired Brain Injury
• Anomia
• Aphasia
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Change
• Traumatic Brain Injury
• Word Finding Difficulty
• Wounds and Injuries

Intervention

Device:
• Active Transcranial direct current stimulation
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
• Sham Transcranial direct current stimulation
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Locations

Country	Name	City	State
United States	The University of Texas at Dallas	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Dallas	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

Chiang HS, Mudar RA, Spence JS, Pudhiyidath A, Eroh J, DeLaRosa B, Kraut MA, Hart J Jr. Age-related changes in feature-based object memory retrieval as measured by event-related potentials. Biol Psychol. 2014 Jul;100:106-14. doi: 10.1016/j.biopsycho.2014.05.010. Epub 2014 Jun 6. — View Citation

Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.

Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia.

Kraut MA, Cherry B, Pitcock JA, Anand R, Li J, Vestal L, Henderson VW, Hart J Jr. The Semantic Object Retrieval Test (SORT) in amnestic mild cognitive impairment. Cogn Behav Neurol. 2007 Mar;20(1):62-7. doi: 10.1097/WNN.0b013e3180335f7d. — View Citation

Mudar RA, Chiang HS, Eroh J, Nguyen LT, Maguire MJ, Spence JS, Kung F, Kraut MA, Hart J. The Effects of Amnestic Mild Cognitive Impairment on Go/NoGo Semantic Categorization Task Performance and Event-Related Potentials. J Alzheimers Dis. 2016;50(2):577-90. doi: 10.3233/JAD-150586. — View Citation

Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.

Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.

Schmidt M. Rey Auditory and Verbal Learning Test: A Handbook. Los Angeles: Western Psychological Services; 1996.

Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Controlled Oral Word Association Test	Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Number of Correct Items Generated	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Primary	Category Fluency	Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Primary	The Boston Naming Test	Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Primary	Semantic Object Retrieval Test	Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Number of Correct Retrievals.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Primary	The Delis Kaplan Color Word Interference Test	Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Primary	Rey Auditory Verbal Learning Test and alternative lists	Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	The Trail Making Test (Parts A & B)	Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A&B). Metric: Time to Solution	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	Digit Span Forward & Backward	Evaluation of treatment differences (active versus sham) in change in Digit Span Forward & Backward. Metric: Memory Span	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	Rey-Osterrieth Complex Figure Test	Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	The Digit Symbol Substitution Test	Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	Task-based electroencephalography (EEG) markers during a Go-NoGo task	Evaluation of treatment differences (active versus sham) in EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary	Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task	Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.