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

NCT06990412 | Not Yet Recruiting DMC

• 1 other identifier: NEURACLE-NEO-202501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Tetraplegia; Spinal Cord Injuries (SCI)

Keywords

BCI, NEO, Tetraplegia; Spinal cord injury

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months post-operation

• Adverse Events

  Immediately post-implantation, and at 3-, and 6-months post-operation.

Secondary Outcomes (10)

• ISNCSCI Score of the Participant

  Baseline, and at 3-, and 6-months post-operation.

• ARAT Score for BCI-Assisted Grasping

  2-, and 6-months post-operation

• ARAT Score

  Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).

• Investigator's Overall Device Performance Evaluation

  Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.

• Subject's Overall Device Performance Evaluation

  2-, 3-, and 6-months post-operation.

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Device: NEO

Interventions

NEO DEVICE

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuracle Medical Technology(Shanghai) Co.,Ltd.: lead
• 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

Study Sites (2)

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Tao Liu

CONTACT

+021-58086056; liutao@neuracle.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 25, 2025
• Study Start: May 20, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 20, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)