RecruitingNot ApplicableNCT05176392

Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Combined Nonpharmacological Therapies for MTBI-Related Headaches


Sponsor

Veterans Medical Research Foundation

Enrollment

240 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a brain stimulation technique called transcranial magnetic stimulation (TMS) — which uses magnetic pulses applied to the outside of your head — combined with therapy can reduce chronic headaches in people who suffered a mild traumatic brain injury (concussion). **You may be eligible if:** - You have a history of mild traumatic brain injury (concussion) - You have had chronic headaches for more than 3 months since your injury - You are between 18 and 65 years old - Your headaches are moderate to severe (pain rated above 30 out of 100) - You did not have daily headaches before your injury - You have not previously had TMS treatment **You may NOT be eligible if:** - You are pregnant - You have a pacemaker or metal implants in your body that would prevent an MRI - You have a history of dementia, bipolar disorder, or schizophrenia - You have other chronic pain conditions affecting the nervous system - You have a history of seizures - You have active suicidal thoughts or recent substance dependence - You cannot understand English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive rTMS

Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.

BEHAVIORALHeadache Management Therapy

Therapy will be provided on headache management.

DEVICESham rTMS

Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.

BEHAVIORALHeadache Education Control

In the control, educational sessions on headaches will be provided.


Locations(1)

VA San Diego Healthcare System

San Diego, California, United States

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NCT05176392


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