RecruitingNot Applicable

BCI-Assisted SCS-EXS for Gait Optimization

China3 participantsStarted 2025-04-23

Plain-language summary

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.

Who can participate

Age range

14 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 14-65 years, any gender. * Clinical diagnosis of spinal cord injury (SCI) due to trauma, inflammation, tumor, vascular disease, or iatrogenic factors, confirmed by medical history, physical examination, and ancillary tests, resulting in lower limb motor dysfunction. * SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours daily) without significant improvement in motor function in the past 2 months. * ASIA Impairment Scale (AIS) grade A, B, or C based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). * Good general health with a life expectancy ≥12 months. * Mini-Mental State Examination (MMSE) score ≥22. * Educational attainment of secondary school or above. * Willingness to participate, provide informed consent, and comply with study follow-up. Exclusion Criteria: * Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke), lower limb vascular diseases (e.g., lower limb vascular occlusion), peripheral nerve diseases, or lower limb bone diseases (e.g., osteoarthritis, joint contracture). * Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g., heartbeat, respiration, swallowing). * Congenital or acquired structural abnormalities of th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The content and number of AEs as well as their severity according to CTCAE v6.0

Timeframe: 0-12 months post-implantation

Trial details

NCT IDNCT06939660

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

Contact for this trial

Penghao Liu, Doctor

+86-17604300002 liuph14@hotmail.com

View on ClinicalTrials.gov More Spinal Cord Injuries (SCI) trials