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New treatment option for Spinal Cord Injuries (SCI)
Official title BCI-Assisted SCS-EXS for Gait Optimization
ClinicalTrials.gov ID: NCT06939660
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65
You may be able to join 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...
- SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours...
- 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.
You likely can't join if
- Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke)...
- Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g...
- 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...
- Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants...
- Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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)...
- 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%...
- 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...
- 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...
- 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...
- 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 people, 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.