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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Tetraplegia; Spinal Cord Injuries (SCI)
• Intervention / Treatment: Device: NEO

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Liu; Phone Number: +021-58086056; Email: liutao@neuracle.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital，Capital Medical University
      • Principal Investigator: Guoguang Zhao, Ph.D
      • Contact: Guoguang Zhao, Ph.D; Phone Number: 010-83192591; Email: ggzhao@vip.sina.com
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Ying Mao, Ph.D; Phone Number: +86 21 5288 8045; Email: maoying@fudan.edu.cn
      • Principal Investigator: Ying Mao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 65 years old, no restriction on gender.
2. Tetraplegia caused by cervical spinal cord injury.
3. Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test).
4. Muscle strength of finger flexors < grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury).
5. 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."
6. Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified.
7. Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment.
8. Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial.

Exclusion Criteria:

1. Without the consent of the patient or the patient's legal guardian.
2. Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training.
3. Requires ventilator support.
4. Baclofen dosage >30 mg/day.
5. 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.
6. High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000.
7. Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system.
8. 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.
9. Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome.
10. Autoimmune-mediated spinal cord dysfunction/injury.
11. History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy.
12. Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies).
13. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO	Device: NEO; a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISNCSCI Score of the Participant	The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form.	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.	2-, and 6-months post-operation
ARAT Score	Investigators will complete the ARAT (Action Research Arm Test) Assessment Form.	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.	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.	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.	1, 2-, 3-, and 6-months post-operation.
Average Monthly Device Usage Time	Calculate the total device usage time per month for each participant.	2-, 3-, and 6-months post-operation.
Participant Quality of Life Score	Assessment Method: Participants complete the "Quality of Life Questionnaire"	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.	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.	1-, 2-, 3-, and 6-months post-operation.

Collaborators and Investigators

• Sponsor: Neuracle Medical Technology(Shanghai) Co.,Ltd.
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital of Central South University; Beijing Tiantan Hospital; Peking University Third Hospital; Huashan Hospital; West China Hospital; Tongji Hospital; First Affiliated Hospital of Fujian Medical University; Xuanwu Hospital, Beijing; Henan Provincial People's Hospital; Affiliated Hospital of Nantong University; The General Hospital of Eastern Theater Command

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: May 7, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Spinal cord injury; BCI, NEO, Tetraplegia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: NEURACLE-NEO-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No