Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation

Официальное название

The Comparison of Safety and Treatment Results Between Early (<6 Months) and Late (> 6 Months) Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial

Обзор

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.

Вмешательства

• Устройство Vagus Nerve Stimulation in early stage
  Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region.
• Устройство Vagus Nerve Stimulation in late stage
  Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region

Первичные конечные точки

• FM-UE scores between early and late VNS [Срок оценки: 12 months after device implantation]

Вторичные конечные точки (6)

• Arm Motor Ability Test (AMAT) between early and late VNS [Срок оценки: 12 months after device implantation]
• the Nine-Hole Peg Test between early and late VNS [Срок оценки: 12 months after device implantation]
• the Bilateral Box and Block Test between early and late VNS [Срок оценки: 12 months after device implantation]
• Short Form Health Survey (SF-12) between early and late VNS [Срок оценки: 12 months after device implantation]
• the EuroQol Five Dimensions Questionnaire (EQ-5D) between early and late VNS [Срок оценки: 12 months after device implantation]
• safety and feasibility of early and late VNS [Срок оценки: 12 months after device implantation]

Критерии участия

Критерии включения

• Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery.

• Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
• Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).

Критерии исключения

• Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination < 24)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT06938243 · Early VNS for Motor Rehabilita

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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