Using brain-computer interface technology to improve walking in spinal cord injury patients

Spatiotemporal Spinal Cord Stimulation Based on Implantable Brain-machine Interfaces and Exoskeletons for Spinal Cord Injury (BASEGO)

This study is testing a new brain-computer interface system to see if it can help people with spinal cord injuries walk better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06939660 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system for individuals with spinal cord injuries (SCI). The study aims to determine if this innovative system can enhance lower limb motor function and improve the quality of life for patients with chronic SCI. Participants will undergo BCI implantation and subsequent rehabilitation using the BCI-SCS-EXS system. The trial focuses on adults aged 14-65 years who have experienced SCI for at least six months and have not seen significant improvement from conventional rehabilitation methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 14-65 with chronic spinal cord injuries classified as ASIA A, B, or C.

Not a fit: Patients with acute spinal cord injuries or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for patients with spinal cord injuries.

How similar studies have performed: Other studies have shown promise with similar brain-computer interface approaches, indicating potential for success in this novel application.

Eligibility criteria

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 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.
* History of psychotropic drug abuse that is not controllable or presence of mental disorders, including major psychiatric illnesses (e.g., depression \[BDI score \>20\], anxiety, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorders, consciousness disorders).
* Pregnant, breastfeeding, planning to conceive, or women of childbearing potential without reliable contraception.
* Participation in other clinical trials within the past month.
* Cognitive impairments or poor compliance from subjects, family members, or caregivers, or inability to complete at least 12 months of follow-up and rehabilitation training.
* Other conditions that increase the risk of study participation or device use, as determined by the investigator.

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital ,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Penghao Liu, Doctor

Conditions Spinal Cord Injuries; Spinal Cord Injury, Chronic; Spinal Cord Injury; Spinal Cord Injury Cervical; Spinal Cord Injury Thoracic; Motor Impairment; Motor Deficits; Gait Training