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Managing Mild Traumatic Brain Injury Related Headaches With Repetitive Transcranial Magnetic Stimulation

NCT03314584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2025-08-07

Study results available
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Summary

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.

Conditions

  • Traumatic Brain Injury (TBI)

Interventions

DEVICE

Transcranial Magnetic Stimulation

Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.

DEVICE

Sham Transcranial Magnetic Stimulation

Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex due to the use of a double sided Active/Sham coil used specifically for research studies.

DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI)

Brain imaging will be done via MRI prior to the first rTMS/Sham TMS session. Imaging will allow investigators to target specific areas in the brain.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Albert Yick Leung, MD · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-09-30
Completion
2024-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314584 on ClinicalTrials.gov