Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation

Официальное название

The Comparison of Treatment Results Between Cerebellar DBS and 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 this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.

Вмешательства

• Устройство Bilateral Cerebellar deep brain stimulation
  Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then bilateral stimulation was activated after 1 month post-DBS
• Устройство Unilateral Cerebellar deep brain stimulation
  Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then unilateral stimulation was activated after 1 month post-DBS
• Устройство Vagus Nerve Stimulation
  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 cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]

Вторичные конечные точки (8)

• Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• the Nine-Hole Peg Test between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• the Bilateral Box and Block Test between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• Short Form Health Survey (SF-12) between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• nerve conduction velocity between cerebellar DBS and VNS [Срок оценки: 12 months after device implantation]
• safety and feasibility of VNS and cerebellar DBS [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 12-36 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

• Chao Zhang — Цзинань

Идентификаторы

NCT: NCT06303960 · VNS or DBS for stroke

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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