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Tests treatment safety and results for Spinal Cord Injury
Official title A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety
ClinicalTrials.gov ID: NCT07720882
What this study is testing
- What it's testing
- This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 18 years ≤ age ≤ 65 years, male or female;
- Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C;
- Severe impairment of hand function on the target upper extremity: finger flexor muscle strength \< grade 3 as assessed by the ISNCSCI scale;
- ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip...
- Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes;
You likely can't join if
- Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia;
- Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe...
- Malignancies in other organ systems;
- Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension;
- Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy...
- Presence of psychiatric or psychological disorders that may interfere with the subject's participation in BCI training, such as depression (HAMD ≥ 18...
See the full eligibility criteria
- 18 years ≤ age ≤ 65 years, male or female;
- Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C;
- Severe impairment of hand function on the target upper extremity: finger flexor muscle strength \< grade 3 as assessed by the ISNCSCI scale;
- ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip, and pinch tasks;
- Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes;
- At least 12 months have elapsed since the cervical spinal cord injury resulting in tetraplegia, and the condition has been stable for at least 6 months following standardized treatment (with documentation of...
- Good cognitive function: Mini-Mental State Examination (MMSE) score ≥ 22 and Montreal Cognitive Assessment (MoCA) score ≥ 26 ;
- Possess the basic visual, auditory, and language comprehension abilities required for interaction, and be able to cooperate with training;
- The subject voluntarily participates and is willing to comply with the relevant examinations and follow-up visits.
- Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia;
- Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe cerebrovascular disease; brain tumor; moderate-to-severe sequelae of...
- Malignancies in other organ systems;
- Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension;
- Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.);
- Presence of psychiatric or psychological disorders that may interfere with the subject's participation in BCI training, such as depression (HAMD ≥ 18 points) or anxiety disorder (HAMA ≥ 14 points) ;
- Presence of active infection; severe coagulation abnormalities (activated partial thromboplastin time (APTT) or prothrombin time (PT) \> 2.5 × upper limit of normal); or other severe systemic diseases that, as assessed...
- Contraindications to surgery or anesthesia, or deemed unsuitable for implantation surgery by anesthesiology/surgical assessment;
- Fever, or vital signs and/or intracranial status not yet stabilized;
- Upper-limb motor dysfunction due to other etiologies, such as amyotrophic lateral sclerosis, syringomyelia, spinal vascular diseases, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis...
- Planned MRI examination during the device implantation period;
- Life expectancy \< 6 months (e.g., severe end-stage diseases);
- Participation in other drug or medical device clinical trials within the past 1 month;
- Pregnant or breastfeeding women;
- Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai 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.