Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

NANot yet recruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

October 30, 2029

Study Completion Date

October 30, 2030

Conditions
Stroke SequelaeDeep Brain StimulationVagus Nerve StimulationMotor RecoveryStrokeHemiplegia
Interventions
PROCEDURE

The DBS electrodes are implanted into MLR.

MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy,exercise training rehabilitation and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide guidance on rehabilitation training and electrical stimulation therapy.

PROCEDURE

The electrodes are implanted into the patient's vagus nerve

A pre-surgery assessment was performed. 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)

Unknown

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT06121947 - Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia | Biotech Hunter | Biotech Hunter