A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

Официальное название

A Prospective, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

Обзор

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.

Вмешательства

• Устройство NEO
  a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

Первичные конечные точки

• BCI-assisted ARAT grasp response rate [Срок оценки: 3 months post-operation]
• Adverse Events [Срок оценки: Immediately post-implantation, and at 3-, and 6-months post-operation.]

Вторичные конечные точки (10)

• ISNCSCI Score of the Participant [Срок оценки: Baseline, and at 3-, and 6-months post-operation.]
• ARAT Score for BCI-Assisted Grasping [Срок оценки: 2-, and 6-months post-operation]
• ARAT Score [Срок оценки: Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).]
• Investigator's Overall Device Performance Evaluation [Срок оценки: Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.]
• Subject's Overall Device Performance Evaluation [Срок оценки: 2-, 3-, and 6-months post-operation.]
• Device Impedance [Срок оценки: 1, 2-, 3-, and 6-months post-operation.]
• Average Monthly Device Usage Time [Срок оценки: 2-, 3-, and 6-months post-operation.]
• Participant Quality of Life Score [Срок оценки: Baseline, and at 2-, 3-, and 6-months post-operation.]
• Subject Satisfaction Rating [Срок оценки: 2-, 3-, and 6-months post-operation.]
• Investigator Satisfaction with Device Operation [Срок оценки: 1-, 2-, 3-, and 6-months post-operation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 2 центра

• Xuanwu Hospital，Capital Medical University — Пекин
• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06990412 · NEURACLE-NEO-202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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