Combining brain stimulation and therapy for headaches after mild brain injuries
Combined Nonpharmacological Therapies for MTBI-Related Headaches
This study is testing if combining brain stimulation with therapy can help veterans and active military personnel manage headaches caused by mild brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05176392 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) combined with telehealth therapy in managing headaches related to mild traumatic brain injury (mTBI). A total of 240 veterans or active military personnel will be enrolled and randomized into four groups to receive either active or sham rTMS along with headache management or education. Participants will undergo a series of in-person visits and telehealth sessions over a period of 6-7 months, including assessments to evaluate headache symptoms and neurobehavioral outcomes. The goal is to determine if the combined approach leads to a significant reduction in headache severity compared to placebo treatments.
Who should consider this trial
Good fit: Ideal candidates are veterans or active military individuals aged 18-65 with chronic headaches following a mild traumatic brain injury.
Not a fit: Patients with a history of major psychiatric disorders, chronic headache conditions prior to mTBI, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate headache symptoms in patients suffering from mTBI.
How similar studies have performed: Other studies have shown promise with rTMS for headache management, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Mild Traumatic Brain Injury (mTBI) 2. Chronic headaches \> 3 months after injury 3. Aged 18-65 4. No prior TMS treatment 5. Persistent Headaches with an intensity \> 30 / 100 6. No history of daily headache prior to mTBI Exclusion Criteria: 1. Pregnant 2. Pacemaker or any metal in body that would prevent MRI 3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia 4. Presence of any other chronic neuropathic pain states 5. History of seizure 6. Pending litigation 7. Can't understand English 8. History of chronic headache like migraine prior to mTBI 9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
Where this trial is running
San Diego, California
- VA San Diego Healthcare System — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Albert Y Leung, MD — San Diego Veterans Healthcare System
- Study coordinator: Caleb Lopez, BS
- Email: caleb.lopez@va.gov
- Phone: 858-552-8585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.