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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

June 7, 2025

Study Completion Date

March 7, 2026

Conditions
Stroke
Interventions
DEVICE

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

DEVICE

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

DEVICE

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.

Trial Locations (1)

250100

RECRUITING

Chao Zhang, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER