Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region(MLR) for Poststroke Hemiplegia

NANot yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

September 10, 2023

Primary Completion Date

December 12, 2025

Study Completion Date

November 11, 2027

Conditions
Stroke Sequelae
Interventions
PROCEDURE

MLR-DBS

"An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into theMLR. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously. Device: MLR-DBS devices~(1) DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); (2) Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); (3) Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China)."

PROCEDURE

Conventional rehabilitation group

An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into theMLR. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.The latter will receive the same rehabilitation training under the face-to-face guidance of specialists except for the power-on (sham stimulation, power-on stimulation parameter is 0).

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT05968248 - Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region(MLR) for Poststroke Hemiplegia | Biotech Hunter | Biotech Hunter