NCT03314584

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

Long Term Efficacy of rTMS in Managing MTBI-related Headache

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Headache is one of the most common debilitating chronic pain conditions in either active or retired military personnel with MTBI. This high prevalence of persistent chronic headache is often associated with neuropsychological dysfunction in mood, attention, and memory, which casts a profound negative impact on patients' quality of life and increases stress in their caregivers. Unfortunately, as witnessed by the investigators in their clinical practices, conventional pharmacological treatments for MTBI related headache (MTBI-HA) has not been shown to be effective and drugs such as narcotics contain many long-term untoward psychosomatic and abusive side effects. This calls for an urgent need in developing alternate and innovative long-term headache management strategies for this rapidly increasing patient population. Coinciding with other published treatment protocols related to traumatic brain injury and pain, this initial clinical evidence provides compelling support for the current proposal aiming to assess the effect of a longer duration of rTMS protocol in managing MTBI-HA for up to 10 weeks after the initiation of the treatment. Given existing treatment options for MTBI-HA are limited, validating such a non-pharmacological and non-invasive treatment option will significantly enhance the capability of the VA healthcare system in caring for this rapidly increasing patient population. 1. PRE-TREATMENT PHASE (weeks 1-2) consists of Visit 1 (Screening Visit) and Visit 2 (Pre-treatment Assessments); 2. TREAMENT PHASE (week 3-4) consists of Visits 3-12 (Neuronavigation guided rTMS consisting of 10 weekday treatments at \>24 and \< 72 hours apart, weekends excluded, maximum 5 weeks for treatment completion) rTMS will take place in Building 23 Room 105 at the VASDHS; and 3. POST-TREATMENT PHASE (week 5-14) consists of two initial weekly visits (Visits 13\&14) and two additional biweekly visits (Visits 15\&16) and one monthly visit (Visit 17). Brain anatomical and functional MRI will be performed within 72 hours after Visits 2 and 13. Subjects will be required to fill out headache diary between assessment visits. Headache assessments along with quality of life, mood and functions assessments will be carried out at Visits 1,2, and 13--17. This frequency of treatment and duration of follow-up is in line with recently published rTMS articles related to TBI, headache and pain, and also in accordance with the 3-month post treatment initiation follow-up guideline/recommendation.

Conditions

• Traumatic Brain Injury (TBI)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-09-30
• Completion: 2024-01-31
• First posted: 2017-10-19
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study