BCI-Assisted SCS-EXS for Gait Optimization

NARecruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 23, 2025

Primary Completion Date

May 1, 2026

Study Completion Date

April 30, 2027

Conditions
Spinal Cord Injuries (SCI)Spinal Cord Injury, ChronicSpinal Cord InjurySpinal Cord Injury CervicalSpinal Cord Injury ThoracicSpinal Cord Injury (Quadraplegia)Motor ImpairmentMotor DeficitsGait TrainingGait Impairment
Interventions
DEVICE

BCI-SCS-EXS

"Participants will undergo a BCI-SCS-EXS intervention designed to enhance neurorehabilitation for spinal cord injury (SCI). The intervention includes:~1. BCI Implantation: High-density ECoG electrodes placed over the motor cortex to decode lower limb movement intent.~2. SCS Electrode Implantation: 5-6-5 paddle electrodes implanted at T11-L2 to deliver targeted spinal cord stimulation.~3. System Calibration: BCI-SCS synchronization to trigger stimulation parameters based on decoded motor intent. SCS-EXS integration to provide synchronized gait assistance.~4. Rehabilitation Training: Daily training sessions (60 minutes, 5 times/week for 1 year) combining BCI-SCS-EXS.~5. Follow-Up: Safety and efficacy assessments at 1, 2, 3, 6, and 12 months post-intervention.~This intervention aims to promote neuroplasticity and functional recovery through brain-controlled spinal activation and synchronized exoskeleton assistance."

Trial Locations (1)

100053

RECRUITING

Xuanwu Hospital ,Capital Medical University, Beijing

All Listed Sponsors
collaborator

Beijing Xinzhida Neural Technology Co., Ltd

UNKNOWN

collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

collaborator

Hangzhou RoboCT Technology Development Co.,Ltd

UNKNOWN

lead

Xuanwu Hospital, Beijing

OTHER

NCT06939660 - BCI-Assisted SCS-EXS for Gait Optimization | Biotech Hunter | Biotech Hunter