Traumatic Brain Injury (TBI) Clinical Trial
Official title:
Long Term Efficacy of rTMS in Managing MTBI-related Headache
Verified date | February 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Persistent headache is one of the most common debilitating symptoms in military personnel suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.
Status | Completed |
Enrollment | 179 |
Est. completion date | January 31, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - The following diagnostic criteria for MTBI based on the 1993 American Congress of Rehabilitation Medicine and recent recommendation from the DOD, and the current diagnostic criteria adopted by the VASDHS TBI Clinic will be used for the study. A traumatically induced physiological disruption of brain function, as manifested by at least one of the following: - any loss of consciousness - any loss of memory for events immediately before or after the accident - any alteration in mental state at the time of the accident, e.g.: - feeling dazed - disoriented - confused) - Focal neurologic deficit (s) that may or may not be transient but where the severity of the injury does not exceed the following: - loss of consciousness of approximately 30 min or less - after 30 min, an initial Glasgow Coma Scale score of 13-15 - post-traumatic amnesia not greater than 24 hrs - In addition, the following established diagnostic criteria for " Persistent headache attributed to mild traumatic injury headache" based on the International Classification of Headache Disorder (ICHD-3) will be applied to the study subjects: - A. Any headache fulfilling criteria C and D - B. Traumatic injury to the head has occurred - C. Headache is reported to have developed within 7 d after one of the following: - 1. injury to the head - 2. regaining of consciousness following the injury - 3. discontinuation of medication(s) that impairs the ability to sense or report headache following the injury - D. Headache persists for >3 mo after injury to the head - E. Not better accounted for by another ICHD-3 diagnosis Additional Inclusion Criteria: - no prior experience of TMS treatment - average persistent headache intensity more than 30 on the 0-100 mechanical visual analog scale(M-VAS) at the screening visit (visit 1) and average persistent headache intensity score greater than 3/10 on a numerical rating scale (NRS) reported in the headache diary (between visits 1&2) - no history of daily persistent headache prior to the MTBI incidence Exclusion Criteria: - pregnancy; To be eligible for the study and to ensure no pregnancy risk, you will need to utilize contraception or practice abstinence until your study participation is completed - history of pacemaker implant - any ferromagnetic material in the brain or body that would prohibit the patients from having a brain MRI, e.g.: - bullet fragment - shrapnel - device implant - history of dementia, major psychiatric or life threatening diseases - presence of any other chronic neuropathic pain states; - history of seizure - pending litigation - lack of ability to understand the experimental protocol and to adequately communicate in English - history of chronic headache diagnoses such migraine, tension or cluster headaches prior to the incidence of MTBI. - history of chronic headache prior to the MTBI incidence at a frequency more than once a month lasting more than one hour. - evidence in the chart of recent exacerbation of depressive or anxiety symptoms, active substance dependence, suicidal intent or attempt within the previous month, and/or current psychotic symptoms |
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduce the intensity, frequency and duration of MTBI-headaches | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA) | The measure will be assessed daily from baseline to the 3-month post-treatment follow up visit. | |
Primary | Change from Baseline to Post-Treatment Quality of Life scores | The outcome measure will be quantified through the self-assessed short form impact on quality of life (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 where Lower scores = more disability and higher scores = less disability The sections include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change from Baseline to Post-Treatment Depression scores | The outcome measure will be quantified through the administered Hamilton Scale for Depression. This contains 17 items to be rated (HDRS-17), but four other questions are not added to the total score and are used to provide additional clinical information. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change in attention scores from Baseline to Post-Treatment visits | The outcome measure will be quantified through the Connors continuous performance test for sustained and selective attention. This is administered on a laptop and is automatically scored. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change from Baseline to Post-Treatment Global Pain scores. | The outcome measure will be quantified through the self-assessed global pain inventory survey. Pain will be recorded at it's worst, it's best and on average over the previous 24 hours on a 0 to 10 scale. Then the pain's impact on general activity, mood, walking ability, normal work, relationships, sleep and enjoyment of life will be measured on a 0 to 10 scale and added together for an overall Global Pain score. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change from Baseline to Post-Treatment Post Traumatic Stress Disorder (PTSD) scores | The outcome measure will be quantified through the administered CAPS, a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The symptoms are rated for both frequency and intensity; these two scores are summed to provide severity ratings. | The measure will be assessed at the Baseline visit, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change from Baseline to Post-Treatment memory scores | The outcome measure will be quantified through the Hopkins Verbal Learning Test (HVLT-R) for memory. When scoring the HVLT-R, the three learning trials are combined to calculate a total recall score and the delayed recall trial creates the delayed recall score. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Primary | Change from Baseline to Post-Treatment Executive Functioning | The outcome measure will be quantified through the Trail Making Test A and B and Stroop Test for executive functioning. The Trail Making Test consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. And the Stroop Test is a demonstration of interference in the reaction time of a task. | The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. | |
Secondary | Explore the treatment effect on the pain related network of the brain | The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing. | Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up. |
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