Spinal Cord Injuries (SCI), Tetraplegia
Conditions
Keywords
BCI, NEO, Tetraplegia, Spinal cord injury
Brief summary
To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration. Through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.
Interventions
DEVICENEO
a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
Sponsors
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Huashan Hospital
Xuanwu Hospital, Beijing
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Fujian Medical University
Beijing Tiantan Hospital
Henan Provincial People's Hospital
West China Hospital
Affiliated Hospital of Nantong University
The General Hospital of Eastern Theater Command
Peking University Third Hospital
Xiangya Hospital of Central South University
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 65 years old, no restriction on gender. 2. Tetraplegia caused by cervical spinal cord injury. 3. Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test). 4. Muscle strength of finger flexors \< grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury). 5. 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
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 | Description |
|---|---|---|
| Adverse Events | Immediately post-implantation, and at 3-, and 6-months post-operation. | — |
| BCI-assisted ARAT grasp response rate | 3 months post-operation | At 3 months post-operation, the investigator will assess and record the subject's ARAT (Action Research Arm Test) score under BCI-assisted conditions, then compare it with the subject's baseline unassisted ARAT grasp score. The response rate will be calculated as the percentage of responders relative to the total number of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction Rating | 2-, 3-, and 6-months post-operation. | Participants evaluate the device's connectivity, operational performance, structural design, and functional design at each follow-up visit. |
| ISNCSCI Score of the Participant | Baseline, and at 3-, and 6-months post-operation. | The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form. |
| ARAT Score for BCI-Assisted Grasping | 2-, and 6-months post-operation | The investigator completes the ARAT (Action Research Arm Test) scoring form. |
| ARAT Score | Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off). | Investigators will complete the ARAT (Action Research Arm Test) Assessment Form. |
| Investigator's Overall Device Performance Evaluation | Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation. | Investigators will complete the Investigator's Overall Device Performance Evaluation Form. |
| Subject's Overall Device Performance Evaluation | 2-, 3-, and 6-months post-operation. | Subjects will complete the Subject Device Performance Evaluation Questionnaire. |
| Device Impedance | 1, 2-, 3-, and 6-months post-operation. | Record the impedance of each channel; impedance is considered normal if it does not exceed 20 kΩ. |
| Investigator Satisfaction with Device Operation | 1-, 2-, 3-, and 6-months post-operation. | At the 1, 2, 3 and 6-month follow-up visits, investigators evaluate the device's connectivity and stability, as well as its electromagnetic compatibility. |
| Average Monthly Device Usage Time | 2-, 3-, and 6-months post-operation. | Calculate the total device usage time per month for each participant. |
| Participant Quality of Life Score | Baseline, and at 2-, 3-, and 6-months post-operation. | Assessment Method: Participants complete the "Quality of Life Questionnaire" |
Countries
China
Outcome results
None listed