Status:
NOT_YET_RECRUITING
A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia
Lead Sponsor:
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Collaborating Sponsors:
Huashan Hospital
Xuanwu Hospital, Beijing
Conditions:
Tetraplegia
Spinal Cord Injuries (SCI)
Eligibility:
All Genders
18-65 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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).
- 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."
- Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified.
- Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment.
- Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial.
Exclusion
- 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.
- 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.
- High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000.
- Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system.
- 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.
- Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome.
- Autoimmune-mediated spinal cord dysfunction/injury.
- History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy.
- Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies).
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06990412
Start Date
May 20 2025
End Date
May 20 2026
Last Update
May 25 2025
Active Locations (2)
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1
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040