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Combined TMS and Therapy for TBI-Related Headaches

This study is looking at how well a combination of repetitive transcranial magnetic stimulation (rTMS) and therapy helps veterans and active military members with headaches after a mild traumatic brain injury (mTBI). rTMS is a device that uses magnetic fields to stimulate nerve cells in the brain. The study wants to see if active rTMS combined with telehealth therapy can significantly reduce headaches and other symptoms compared to a sham (inactive) rTMS or basic headache education. You might be able to join if you are 18-65 years old, have chronic headaches for over 3 months after an mTBI, and your headache intensity is greater than 30 out of 100. The study is currently recruiting 240 participants.

Study design
This is an interventional study with 240 participants, randomized into one of four groups to receive either active rTMS or sham rTMS, combined with either headache management therapy or headache education.
What's involved
Your participation would involve 19 in-person visits to the VA San Diego Healthcare System and 11 telehealth sessions over about 6-7 months. This includes screening, baseline assessments with an MRI, 10 rTMS treatment sessions, and several follow-up assessments.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for changes in headache intensity and frequency for up to 20 weeks after your baseline visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05176392

Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Recruiting
NAAges 18–65InterventionalTreatment
Veterans Medical Research Foundation
~240 participants
Updated 2024-11-21 on ClinicalTrials.gov
What's tested:Active rTMSHeadache Management TherapySham rTMSHeadache Education Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intensity of Persistent Headaches
Measured over Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
+4 more outcomes measured

Conditions

TBI (Traumatic Brain Injury)
Headache
Depression

Explore related trials

HeadacheTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Albert Y Leung, MD · PRINCIPAL_INVESTIGATOR · San Diego Veterans Healthcare System

Who to contact

Caleb Lopez, BS
[email protected]
858-552-8585 · ext. 2638
Email the study team

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What this trial measures

  • Intensity of Persistent HeadachesChange from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

    Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.

  • Intensity of Debilitating HeadachesChange from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

    Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.

  • Persistent Headache FrequencyChange from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

    Assesses the frequency per week of persistent headaches

  • Debilitating Headache FrequencyChange from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

    Assesses the frequency per week of debilitating headaches

  • Debilitating Headache InterferenceChange from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

    Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.