Brain State-dependent PCMS in Chronic Stroke

Официальное название

Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation

Обзор

After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.

Вмешательства

• Комбинированный продукт Brain state-dependent paired corticomotoneuronal stimulation (PCMS)
  Paired corticomotoneuronal stimulation (PCMS) involves delivering precisely timed pairs of transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) so that the neuronal activity evoked by such stimulation arrives synchronously at corticospinal-motoneuronal synapses. This synchronous arrival is postulated to cause long-term potentiation via spike timing-dependent plasticity, which then improves corticospinal transmission and hand function. In this study, paired corticomotone

Первичные конечные точки

• Maximum hand force output [Срок оценки: up to 1 hour after intervention]
• Maximum hand muscle activation [Срок оценки: up to 1 hour after intervention]

Вторичные конечные точки (2)

• Amplitude of motor evoked potentials [Срок оценки: up to 1 hour after intervention]
• Time to complete the 9-hole peg test [Срок оценки: up to 1 hour after intervention]

Критерии участия

Критерии включения

• History of stroke > 6 months ago
• Presence of residual upper extremity hemiparesis
• Willingness to participate
• Ability to provide informed consent
• Upper extremity Fugl-Meyer score < 66
• Mini Mental State Exam score > 24
• Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Критерии исключения

• History of neurological disease other than stroke
• Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
• Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
• Mini Mental State Exam score <= 24
• No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Texas at Austin — Austin

Идентификаторы

NCT: NCT04830163 · STUDY00000896_Exp3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗