Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

NANot yet recruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

December 30, 2024

Study Completion Date

November 30, 2026

Conditions
Cervical Dystonia
Interventions
PROCEDURE

GPi-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 the posteroventral part of bilateral GPi nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.

PROCEDURE

STN-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 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.

DEVICE

GPi-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)."

DEVICE

STN-DBS devices

"1. DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (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)."

Trial Locations (1)

100853

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia | Biotech Hunter | Biotech Hunter