Combining brain stimulation and therapy for headaches after mild brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using external trigeminal nerve stimulation to treat migraines in pregnant women

  This study is trying to see if a device that stimulates a nerve in the face can safely help pregnant women with migraines feel better.

  Recruiting Cefaly Technology · Darien, Connecticut · NCT06788977

• Personalized brain stimulation for long-term symptoms after concussion

  This study will try personalized, noninvasive brain stimulation (TMS) to reduce dizziness, headaches, memory problems, and other lasting symptoms in adults aged 18–65 after a concussion.

  Recruiting Phase 2 University of California, Los Angeles · Westwood, Los Angeles, California · NCT06073886

• Cognitive training for improving mental health in forensic patients

  This study is testing if a special brain training program can help improve thinking skills and mental health for people in a secure facility.

  Recruiting The Royal Ottawa Mental Health Centre · Ottawa, Ontario · NCT04610697

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.