Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Not Applicable

Recruiting

• Conditions: Headache; Brain Concussion; Mild Traumatic Brain Injury; Post-Concussion Symptoms

• Registration Number: NCT06112093
• Lead Sponsor: State University of New York - Upstate Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 - 65 years old who were actively working prior to mTBI<br><br> - mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale<br> between 13 and 15, or post-traumatic amnesia for = 24 hours<br><br> - diagnosis of persistent post-traumatic headache according to the International<br> Classification of Headache Disorders, 3rd edition (ICHD-3) criteria<br><br> - headache develops within 7 days after head trauma<br><br> - headache persists for >=3 months after head trauma despite receiving standard care<br><br> - average persistent headache intensity is >= 3/10 of the numerical rating scale (NRS)<br> on >=3days/week<br><br> - no evidence of radiculopathy or peripheral neuropathy on electromyography or<br> clinical evaluation<br><br> - no evidence of other possible causes of headaches<br><br>Exclusion Criteria:<br><br> - history of chronic headache diagnoses such as migraine, tension, or cluster<br> headaches prior to the incidence of mTBI<br><br> - history of other neurologic conditions with medications affecting the central<br> nervous system<br><br> - contraindications of receiving TMS (e.g., a history of epileptic seizure and having<br> implants like a cardiac pacemaker or intracerebral vascular clip

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily headache diary - intensity;Daily headache diary - frequency;Daily headache diary - duration;Patient-Reported Outcomes Measurement Information System (PROMIS);Headache impact test 6 (HIT-6);Post-Concussion Symptom Scale (PCSS);Rivermead Post-Concussion Symptoms Questionnaire (RPQ);Wrist actigraphy - sleep quality;Wrist actigraphy - physical activity level;Neurophysiological measures by TMS;Gene expression

Secondary Outcome Measures

Name	Time	Method
Length of rehabilitation (LOR);Return to work (RTW)