Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Phase 1RecruitingNCT06112093

State University of New York - Upstate Medical University60 enrolled

Overview

This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Brain Concussion Mild Traumatic Brain Injury Headache Post-Concussion Symptoms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Daily headache diary

Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).

Time frame: daily documentation throughout the treatment course (4 weeks)

Patient-Reported Outcomes Measurement Information System (PROMIS)

The PROMIS questionnaires with subsections of 1) pain interference, 2) pain behavior will be used as patient-reported outcomes of pain and sleep. For all subsections, on a scale of 1 to 5, higher numbers indicate worse outcomes.

Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up

Protein expression

Peripheral blood will be collected to measure protein expression

Time frame: baseline, immediately post-treatment (completion of rTMS)

Neurophysiological measures by TMS

Neurophysiology will be measured by TMS to indicate changes in brain function.

Time frame: baseline, immediately post-treatment (completion of rTMS)

Headache impact test 6 (HIT-6)

The HIT-6 will be used to assess the impact of headaches on one's ability to function in occupational and social lives. On a scale of 36 to 78, higher numbers indicate worse outcomes.

Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up

Post-Concussion Symptom Scale (PCSS)

The change in global post-concussion symptoms will be measured by the PCSS. On a scale of 1 to 5, higher numbers indicate worse outcomes.

Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up

Wrist actigraphy - physical activity level

Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.

Time frame: baseline, immediately post-treatment (completion of rTMS)

Gene expression

Peripheral blood will be collected to measure mRNA to impute gene expression.

Time frame: baseline, immediately post-treatment (completion of rTMS)

Secondary Outcomes

Wrist actigraphy - sleep quality

Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality.

Time frame: baseline, immediately post-treatment (completion of rTMS)

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts