Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Repetitive Transcranial Magnetic Stimulation
  rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
• Устройство 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.

Первичные конечные точки

• Daily headache diary [Срок оценки: daily documentation throughout the treatment course (4 weeks)]
• Patient-Reported Outcomes Measurement Information System (PROMIS) [Срок оценки: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Protein expression [Срок оценки: baseline, immediately post-treatment (completion of rTMS)]
• Neurophysiological measures by TMS [Срок оценки: baseline, immediately post-treatment (completion of rTMS)]
• Headache impact test 6 (HIT-6) [Срок оценки: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Post-Concussion Symptom Scale (PCSS) [Срок оценки: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up]
• Wrist actigraphy - physical activity level [Срок оценки: baseline, immediately post-treatment (completion of rTMS)]
• Gene expression [Срок оценки: baseline, immediately post-treatment (completion of rTMS)]

Вторичные конечные точки (1)

• Wrist actigraphy - sleep quality [Срок оценки: baseline, immediately post-treatment (completion of rTMS)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• SUNY Upstate Medical University — Syracuse

Публикации

• 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

Идентификаторы

NCT: NCT06112093 · 1825424

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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