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Recruiting NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Phase I Interventional Brain Concussion Mild Traumatic Brain Injury Headache Post-Concussion Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Brain Concussion, Mild Traumatic Brain Injury, Headache, Post-Concussion Symptoms. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation
    rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
  • Device Sham Repetitive Transcranial Magnetic Stimulation
    Sham rTMS will be delivered by a sham coil as a comparator to the (active) rTMS. Sham rTMS will not change the brain function of the control group.

Primary outcome measures

  • Daily headache diary [Time frame: daily documentation throughout the treatment course (4 weeks)]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up]
  • Protein expression [Time frame: baseline, immediately post-treatment (completion of rTMS)]
  • Neurophysiological measures by TMS [Time frame: baseline, immediately post-treatment (completion of rTMS)]
  • Headache impact test 6 (HIT-6) [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) [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 [Time frame: baseline, immediately post-treatment (completion of rTMS)]
  • Gene expression [Time frame: baseline, immediately post-treatment (completion of rTMS)]
Secondary outcome measures (1)
  • Wrist actigraphy - sleep quality [Time frame: baseline, immediately post-treatment (completion of rTMS)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • SUNY Upstate Medical University — Syracuse

Publications

  • Iverson GL, Gardner AJ, Terry DP, Ponsford JL, Sills AK, Broshek DK, Solomon GS. Predictors of clinical recovery from concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):941-948. doi: 10.1136/bjsports-2017-097729. PMID 28566342
  • De Kruijk JR, Leffers P, Menheere PP, Meerhoff S, Rutten J, Twijnstra A. Prediction of post-traumatic complaints after mild traumatic brain injury: early symptoms and biochemical markers. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):727-32. doi: 10.1136/jnnp.73.6.727. PMID 12438478
  • Minen MT, Boubour A, Walia H, Barr W. Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues. Curr Neurol Neurosci Rep. 2016 Nov;16(11):100. doi: 10.1007/s11910-016-0697-7. PMID 27709555
  • Bomyea J, Lang AJ, Delano-Wood L, Jak A, Hanson KL, Sorg S, Clark AL, Schiehser DM. Neuropsychiatric Predictors of Post-Injury Headache After Mild-Moderate Traumatic Brain Injury in Veterans. Headache. 2016 Apr;56(4):699-710. doi: 10.1111/head.12799. Epub 2016 Mar 29. PMID 27028095
  • Howard L, Schwedt TJ. Posttraumatic headache: recent progress. Curr Opin Neurol. 2020 Jun;33(3):316-322. doi: 10.1097/WCO.0000000000000815. PMID 32304441
  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principl PMID 25797650
  • Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wasse PMID 33243615
  • Major BP, Rogers MA, Pearce AJ. Using transcranial magnetic stimulation to quantify electrophysiological changes following concussive brain injury: a systematic review. Clin Exp Pharmacol Physiol. 2015 Apr;42(4):394-405. doi: 10.1111/1440-1681.12363. PMID 25603731

Identifiers

NCT: NCT06112093 · 1825424

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗