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.
Age between 18 and 65 years old, no restriction on gender.
Tetraplegia caused by cervical spinal cord injury.
Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test).
Muscle strength of finger flexors < grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury).
Without the consent of the patient or the patient's legal guardian.
Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training.
Requires ventilator support.
Baclofen dosage >30 mg/day.
Single group
NEO
Devicea Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
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.
Adverse Events
ISNCSCI Score of the Participant
The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form.
ARAT Score for BCI-Assisted Grasping
The investigator completes the ARAT (Action Research Arm Test) scoring form.
ARAT Score
Investigators will complete the ARAT (Action Research Arm Test) Assessment Form.
Investigator's Overall Device Performance Evaluation
Investigators will complete the Investigator's Overall Device Performance Evaluation Form.
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Neuracle Medical Technology(Shanghai) Co.,Ltd.
Lead sponsor
Huashan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Beijing Tiantan Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
West China Hospital
Collaborator
Affiliated Hospital of Nantong University
Collaborator
The General Hospital of Eastern Theater Command
Collaborator
Peking University Third Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Tongji Hospital
Collaborator
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