BCI-Assisted SCS-EXS for Gait Optimization

NCT06939660 | Recruiting

• 1 other identifier: BRWEP2024W022010200-SCS01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation?
2. 2.Does the system improve lower limb motor function and quality of life in SCI patients?

Conditions

Spinal Cord Injuries (SCI); Spinal Cord Injury, Chronic; Spinal Cord Injury; Spinal Cord Injury Cervical; Spinal Cord Injury Thoracic; Spinal Cord Injury (Quadraplegia); Motor Impairment; Motor Deficits; Gait Training; Gait Impairment

Keywords

Brain-computer interface; Spianl cord stimulation; Exoskeleton; Rehabilitation; Spinal cord injury; Motor dysfunction; BCI; Brain-spinal interface; BSI; Brain-machine interface; Gait training; Neural plasticity

Outcome Measures

Primary Outcomes (1)

• 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.

  0-12 months post-implantation

Secondary Outcomes (28)

• Signal Acquisition Normal Rate of BCI

  0, 1, 2, 3, 6, 12 months post-implantation

• Electrode Impedance of BCI electrodes

  0, 1, 2, 3, 6, 12 months post-implantation

• Effective Channel Count of BCI

  0, 1, 2, 3, 6, 12 months post-implantation

• Electrode Impedance Stability of SCS

  0, 1, 2, 3, 6, 12 months post-implantation

• Position Stability of SCS

  0, 3, 6, 12 months post-implantation

Study Arms (1)

BCI-SCS-EXO

EXPERIMENTAL

Participants will undergo a BCI-SCS-EXS intervention, involving implatation of high-density ECoG electrodes, as well as SCS electrodes. The system will be calibrated to synchronize BCI-decoded motor intent with SCS parameters and integrate with the exoskeleton (EXS) to provide synchronized gait assistance. Safety and efficacy assessments will be conducted at 1, 2, 3, 6, and 12 months post-intervention.

Device: BCI-SCS-EXS

Interventions

BCI-SCS-EXS DEVICE

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.

BCI-SCS-EXO

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators).
• Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the device implantation period.
• MRI shows structural damage \>50% in motor function areas (precentral and postcentral gyri, ventromedial sensorimotor areas, mid temporal lobe, Broca's area, Wernicke's area, Geschwind's area), or DTI shows damage \>50% in the posterior limb of the internal capsule.
• Severe cardiovascular disease: Above level II myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms in men, ≥470 ms in women), level III-IV heart failure (NYHA classification), or echocardiography showing LVEF \<50%.
• Coagulation abnormalities (INR \>1.5 ULN, PT \>ULN +4 s, or APTT \>1.5 ULN), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy.
• Severe infections within 4 weeks before surgery (requiring IV antibiotics, antifungals, or antivirals) or lumbar soft tissue infections, or unexplained fever \>38.5℃ during screening or before surgery.
• HIV infection, acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥500 IU/ml), hepatitis C (positive HCV antibody and detectable HCV-RNA), or co-infection of hepatitis B and C.
• Severe cerebrovascular events (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 12 months before enrollment.
• Metastatic malignancies or untreated malignant tumors.
• Major surgery or severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment.
• Addictive habits such as drug abuse or alcoholism.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Xinzhida Neural Technology Co., Ltd: collaborator
• Beijing Pins Medical Co., Ltd: collaborator
• Hangzhou RoboCT Technology Development Co.,Ltd: collaborator

Study Sites (1)

Xuanwu Hospital ,Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (5)

• Gad P, Gerasimenko Y, Zdunowski S, Turner A, Sayenko D, Lu DC, Edgerton VR. Weight Bearing Over-ground Stepping in an Exoskeleton with Non-invasive Spinal Cord Neuromodulation after Motor Complete Paraplegia. Front Neurosci. 2017 Jun 8;11:333. doi: 10.3389/fnins.2017.00333. eCollection 2017.

  PMID: 28642680 BACKGROUND

• Gorgey AS, Gill S, Holman ME, Davis JC, Atri R, Bai O, Goetz L, Lester DL, Trainer R, Lavis TD. The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. Ann Clin Transl Neurol. 2020 Feb;7(2):259-265. doi: 10.1002/acn3.50983. Epub 2020 Feb 5.

  PMID: 32023011 BACKGROUND

• Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.

  PMID: 35132264 BACKGROUND

• Lorach H, Galvez A, Spagnolo V, Martel F, Karakas S, Intering N, Vat M, Faivre O, Harte C, Komi S, Ravier J, Collin T, Coquoz L, Sakr I, Baaklini E, Hernandez-Charpak SD, Dumont G, Buschman R, Buse N, Denison T, van Nes I, Asboth L, Watrin A, Struber L, Sauter-Starace F, Langar L, Auboiroux V, Carda S, Chabardes S, Aksenova T, Demesmaeker R, Charvet G, Bloch J, Courtine G. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023 Jun;618(7963):126-133. doi: 10.1038/s41586-023-06094-5. Epub 2023 May 24.

  PMID: 37225984 BACKGROUND

• Liu P, Cheng Y, Xu Z, Li X, Chen Z, Duan W. Spatiotemporal spinal cord stimulation with real-time triggering exoskeleton restores walking capability: a case report. Ann Clin Transl Neurol. 2025 Mar;12(3):659-665. doi: 10.1002/acn3.52281. Epub 2024 Dec 15.

  PMID: 39675019 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Bronchiolitis Obliterans Syndrome; Quadriplegia; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Paralysis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Penghao Liu, Doctor

CONTACT

+86-17604300002; liuph14@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 23, 2025
• Study Start: April 23, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)