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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
32
a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
BCI-assisted ARAT grasp response rate
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.
Time frame: 3 months post-operation
Adverse Events
Time frame: Immediately post-implantation, and at 3-, and 6-months post-operation.
ISNCSCI Score of the Participant
The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form.
Time frame: Baseline, and at 3-, and 6-months post-operation.
ARAT Score for BCI-Assisted Grasping
The investigator completes the ARAT (Action Research Arm Test) scoring form.
Time frame: 2-, and 6-months post-operation
ARAT Score
Investigators will complete the ARAT (Action Research Arm Test) Assessment Form.
Time frame: Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).
Investigator's Overall Device Performance Evaluation
Investigators will complete the Investigator's Overall Device Performance Evaluation Form.
Time frame: Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.
Subject's Overall Device Performance Evaluation
Subjects will complete the Subject Device Performance Evaluation Questionnaire.
Time frame: 2-, 3-, and 6-months post-operation.
Device Impedance
Record the impedance of each channel; impedance is considered normal if it does not exceed 20 kΩ.
Time frame: 1, 2-, 3-, and 6-months post-operation.
Average Monthly Device Usage Time
Calculate the total device usage time per month for each participant.
Time frame: 2-, 3-, and 6-months post-operation.
Participant Quality of Life Score
Assessment Method: Participants complete the "Quality of Life Questionnaire"
Time frame: Baseline, and at 2-, 3-, and 6-months post-operation.
Subject Satisfaction Rating
Participants evaluate the device's connectivity, operational performance, structural design, and functional design at each follow-up visit.
Time frame: 2-, 3-, and 6-months post-operation.
Investigator Satisfaction with Device 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.
Time frame: 1-, 2-, 3-, and 6-months post-operation.
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