Tetraplegia
Conditions
Interventions
Experimental group:an Implantable Brain Signal Acquisition and Stimulation System NEO
Sponsors
Huashan Hospital Affiliated to Fudan University;
Xuanwu Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: If you answer "no" to any of the following criteria, you will not be allowed to participate in this clinical trial. 1. Age between 18 and 65 years old, no restriction on gender; 2. Tetraplegia caused by cervical spinal cord injury; 3. Score of =2 for "hand to mouth" on ARAT; scores of >=1 for both "hand to top of head" and "hand to behind the head." 6. Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified; 7. Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment; 8. Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: If you answer "yes" to any of the following criteria, you will not be allowed to participate in this clinical trial. 1. Without the consent of the patient or the patient’s legal guardian; 2. Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant’s ability to engage in training; 3. Requires ventilator support; 4. Baclofen dosage >30 mg/day; 5. Received botulinum toxin injections in the upper limb, neck, or hand within 6 months prior to enrollment, or received stem cell therapy within 1 year; 6. High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000; 7. Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system; 8. Any unstable or significant medical condition that may interfere with study procedures or confound the evaluation of study endpoints, such as depression, mood disorders, or other cognitive impairments; 9. Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome; 10. Autoimmune-mediated spinal cord dysfunction/injury; 11. History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy; 12. Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies); 13. In the investigator’s opinion, the study is unsafe or inappropriate for the participant, or the participant is unlikely to comply with the study follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCI-assisted ARAT grasp response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ISNCSCI Score of the Participant;ARAT Score for BCI-Assisted Grasping;ARAT Score;Investigator’s Overall Device Performance Evaluation;Subject's Overall Device Performance Evaluation;Device Impedance;Average Monthly Device Usage Time;Participant Quality of Life Score;Subject Satisfaction Rating;Investigator Satisfaction with Device Operation; | — |
Countries
China
Contacts
Public ContactYing Mao; Zhao Guoguang
Huashan Hospital Affiliated to Fudan University;Xuanwu Hospital,Capital Medical University
Outcome results
None listed