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.
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).
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 the lower limb bones or muscles.
Presence of surgical contraindications (e.g., anesthesia-related adverse reactions, coagulation risks, or surgeon's determination of unsuitability for surgery).
Single group
BCI-SCS-EXS
DeviceParticipants 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.
The content and number of AEs as well as their severity according to CTCAE v6.0
The safety of the BCI-SCS-EXS system is evaluated by focusing on adverse events (AEs) associated with the trial devices (BCI, SCS, and EXS). AEs are documented and categorized according to their severity and relationship to the devices. The primary outcome measure calculated as the content and number of AEs as well as their severity according to CTCAE v6.0. This metric provides an overview of the safety profile of the BCI-SCS-EXS system.
Signal Acquisition Normal Rate of BCI
Signal Acquisition Normal Rate is quantified as the ratio of successfully captured high-quality ECoG signal segments to the total number of predefined-length segments. This metric is calculated by analyzing the proportion of segments that meet predefined quality criteria as signal-to-noise ratio (SNR) \>10 dB. The rate is expressed as a percentage and reflects the reliability of the BCI system in capturing usable signals.
Electrode Impedance of BCI electrodes
Electrode impedance is measured to ensure optimal signal transmission. Impedance is assessed using an EEG acquisition system with a low-noise preamplifier and impedance detection software. The impedance value, expressed in kilohms (kΩ), reflects the resistance between the electrode and scalp.
Effective Channel Count of BCI
The effective channel count is quantified by the number of channels with a signal-to-noise ratio (SNR) exceeding 10 dB. SNR is calculated by analyzing the power spectral density of each channel. The count reflects the system's ability to reliably capture high-quality neural signals.
Electrode Impedance Stability of SCS
Electrode impedance stability is assessed by measuring the impedance of each SCS electrode channel at regular intervals. Impedance is measured using a calibrated impedance meter integrated with the SCS system. The stability is quantified by calculating the coefficient of variation (CV) of impedance values over time. A lower CV indicates more stable impedance.
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Xuanwu Hospital, Beijing
Lead sponsor
Beijing Xinzhida Neural Technology Co., Ltd
Collaborator
Beijing Pins Medical Co., Ltd
Collaborator
Hangzhou RoboCT Technology Development Co.,Ltd
Collaborator
