Actively Recruiting
Combined Nonpharmacological Therapies for MTBI-Related Headaches
Led by Veterans Medical Research Foundation · Updated on 2024-11-21
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combined use of repetitive transcranial magnetic stimulation (rTMS) and telehealth-based therapy to help manage headaches related to mild traumatic brain injury (mTBI). The study involves veterans and active military personnel who experience persistent headaches after mTBI and aims to compare active rTMS with telehealth therapy against placebo treatments in reducing headache intensity and related symptoms. Participants will be randomly assigned to one of four groups combining active or sham rTMS with either telehealth headache management therapy or headache education control. The treatment includes 10 neuronavigation-guided rTMS sessions over two weeks, alongside weekly telehealth sessions for headache therapy or education from weeks 3 to 10, plus three additional monthly booster telehealth sessions. The study spans about 6 to 7 months with multiple phases including pre-treatment assessments, induction treatment, and post-treatment assessments with maintenance treatments. During the 19 in-person visits and 11 telehealth sessions, participants undergo MRI scans and assessments of headaches, neurobehavioral symptoms, depression, post-concussion symptoms, and quality of life. Researchers measure changes in headache intensity, frequency, and interference along with other symptom scales at multiple follow-up visits up to 20 weeks. This comprehensive evaluation helps monitor symptom changes and treatment effects throughout the study period.
CONDITIONS
Brief Title
Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mild Traumatic Brain Injury (mTBI)
- Chronic headaches lasting more than 3 months after injury
- Age between 18 and 65 years
- No prior transcranial magnetic stimulation (TMS) treatment
- Persistent headaches with intensity greater than 30 on a 100-point scale
- No history of daily headaches before mTBI
You will not qualify if you...
- Pregnant
- Presence of pacemaker or any metal in the body preventing MRI
- History of dementia or major psychiatric diseases such as bipolar disorder or schizophrenia
- Other chronic neuropathic pain conditions
- History of seizures
- Pending litigation
- Unable to understand English
- History of chronic headaches like migraine before mTBI
- Recent worsening of depressive or anxiety symptoms, active substance dependence, or suicidal intent within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants complete baseline assessments including an MRI scan to evaluate headaches and related symptoms.
1 visit (in-person)
Duration - 2 weeks
Participants receive 10 weekday neuronavigation guided rTMS sessions combined with telehealth headache management therapy or education.
10 visits (in-person) and weekly telehealth sessions during weeks 3 to 10
Duration - 20 weeks
Participants attend biweekly and monthly post-induction treatment assessments and maintenance treatments, with ongoing telehealth therapy or education sessions.
7 visits (in-person) and 3 telehealth bolster sessions spaced 4 weeks apart
Trial Site Locations
Total: 1 location
1
VA San Diego Healthcare System
San Diego, California, United States, 92161
Actively Recruiting
Research Team
C
Caleb Lopez, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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