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Procedure

rTMS for Post-Concussion Syndrome

N/A

Recruiting

Led By Yi-Ling Kuo, PT, PhD

Research Sponsored by State University of New York - Upstate Medical University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 55 years old who were actively working prior to mTBI

First-ever mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours

Must not have

Contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately post-treatment (completion of rtms), 1-month follow-up, 3-month follow-up

Summary

This trial studies how rTMS, a non-invasive brain stimulation technique, can help reduce chronic headaches from mild traumatic brain injury (mTBI). It aims to improve post-concussion symptoms & reduce costs of delayed recovery.

Who is the study for?

This trial is for adults aged 18-55 who developed headaches within a week after a mild brain injury and have had these headaches persist for at least 3 months despite treatment. Participants must have been working before the injury, lost consciousness for less than 30 minutes, and not have other neurological conditions or chronic headache history.

What is being tested?

The study tests repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain. It's compared with sham rTMS to see if it can reduce long-term headaches caused by mild traumatic brain injuries without medication side effects.

What are the potential side effects?

rTMS is generally considered safe and has fewer side effects than medications; however, some may experience discomfort at the stimulation site, lightheadedness, or temporary hearing changes due to the noise of the machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old and was working before my mild brain injury.

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I had a mild brain injury with brief unconsciousness or confusion.

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I experience headaches with a pain level of 3 or more on most days.

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I don't have nerve damage according to tests or doctor's evaluation.

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My headaches have no other identified cause.

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I have been diagnosed with long-lasting headaches after an injury by a certified brain injury specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have epilepsy, a pacemaker, or brain vessel clips.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately post-treatment (completion of rtms), 1-month follow-up, 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately post-treatment (completion of rtms), 1-month follow-up, 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately post-treatment (completion of rtms), 1-month follow-up, 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily headache diary - duration

Daily headache diary - frequency

Daily headache diary - intensity

+8 more

Secondary study objectives

Length of rehabilitation (LOR)

Return to work (RTW)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Repetitive transcranial magnetic stimulation (rTMS)Active Control1 Intervention

12 sessions (3 sessions/week) of active rTMS at the left motor cortex to upregulate brain excitability and reduce headaches and post-concussion symptoms.

Group II: Sham rTMSPlacebo Group1 Intervention

12 sessions (3 sessions/week) of sham rTMS will be administered at the same location and duration as the active rTMS but will not modulate brain function. After the study is completed, participants will be offered an opportunity to receive active rTMS.

0 / 7Eligibility criteria met