Actively Recruiting
BCI-Assisted SCS-EXS for Gait Optimization
Led by Xuanwu Hospital, Beijing · Updated on 2025-05-20
3
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
B
Beijing Xinzhida Neural Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI. Participant Population: Adults aged 14-65 years (sex/gender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C. Individuals with stable health status, MMSE ≥22, and secondary education or above. Primary Questions: 1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation? 2. Does the system improve lower limb motor function and quality of life in SCI patients? Interventions: Participants will undergo the following procedures: Phase I (Implantation): BCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent. SCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation. Phase II (System Calibration): BCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters. SCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training. Phase III (Rehabilitation): Daily BCI-SCS-EXS training sessions (60 minutes, 5 times/week for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance. Remote monitoring of device performance and emergency intervention for technical issues. Outcome Measures: Primary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life). Ethics and Safety: Informed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines. Participant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.
CONDITIONS
Official Title
BCI-Assisted SCS-EXS for Gait Optimization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 to 65 years, any gender
- Diagnosed spinal cord injury (SCI) from trauma, inflammation, tumor, vascular disease, or iatrogenic causes causing lower limb movement problems
- SCI occurred at least 6 months ago with at least 1 month of continuous rehabilitation without significant motor improvement in past 2 months
- ASIA Impairment Scale grade A, B, or C
- Good general health with expected survival of at least 12 months
- Mini-Mental State Examination score of 22 or higher
- Education level of secondary school or above
- Willingness to participate, give informed consent, and follow study procedures
You will not qualify if you...
- Other diseases affecting lower limb motor function such as brain diseases, lower limb vascular, peripheral nerve, or bone diseases
- Need for continuous medical support for critical functions (e.g., breathing, swallowing)
- Structural abnormalities of lower limb bones or muscles
- Surgical contraindications including anesthesia risks or bleeding disorders
- Active implantable devices except spinal cord stimulation or brain-machine interfaces
- Inability to have implants due to other treatments or need for MRI during implantation period
- MRI or DTI evidence of significant brain damage in motor areas
- Severe cardiovascular diseases including advanced heart failure or serious arrhythmias
- Blood clotting disorders or use of blood thinners
- Severe infections within 4 weeks before surgery or unexplained high fever
- HIV/AIDS, active tuberculosis, active hepatitis B or C, or co-infections
- Recent severe cerebrovascular events, deep vein thrombosis, or pulmonary embolism
- Metastatic or untreated cancers
- Major surgery, severe injuries, fractures, or ulcers within 4 weeks before enrollment
- Substance abuse or alcoholism
- Uncontrolled mental illnesses or major psychiatric disorders
- Pregnancy, breastfeeding, planning pregnancy, or lack of reliable contraception in women of childbearing potential
- Participation in other clinical trials within the last month
- Cognitive impairments or inability to comply with at least 12 months of follow-up and training
- Other conditions increasing study or device risk as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital ,Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
P
Penghao Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here