Using magnetic stimulation to treat headaches after concussions

Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study

This study is testing if a special type of brain stimulation can help people with chronic headaches after a concussion feel better without the side effects of regular medications.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: State University of New York - Upstate Medical University (other)
• Locations: 1 site (Syracuse, New York)
• Trial ID: NCT06112093 on ClinicalTrials.gov

What this trial studies

This study examines the long-term effects of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches that follow mild traumatic brain injury (mTBI). The approach aims to reduce headache symptoms without the side effects associated with traditional medications. Participants will receive either active rTMS or a sham treatment to assess the effectiveness of this intervention. The study also seeks to identify biomarkers that could aid in the diagnosis and prognosis of post-concussion symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 who have experienced a mild traumatic brain injury and have persistent headaches that developed within a week of the injury.

Not a fit: Patients with a history of chronic headache disorders prior to their concussion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic headaches in patients recovering from concussions, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with rTMS for headache management, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 18 - 55 years old
* 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
* diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
* headache develops within 7 days after head trauma
* headache persists for \>=3 months after head trauma despite receiving standard care
* average persistent headache intensity is \>= 3/10 of the numerical rating scale (NRS) on \>=3days/week
* no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation
* no evidence of other possible causes of headaches

Exclusion Criteria:

* history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI
* history of other neurologic conditions with medications affecting the central nervous system
* contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip

Where this trial is running

Syracuse, New York

• SUNY Upstate Medical University — Syracuse, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Yi-Ling Kuo, PT, PhD — State University of New York - Upstate Medical University
• Study coordinator: Yi-Ling Kuo, PT, PhD

Conditions: Brain Concussion, Mild Traumatic Brain Injury, Headache, Post-Concussion Symptoms, Repetitive transcranial magnetic stimulation, Non-invasive brain stimulation, Neuromodulation, Chronic pain