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

August 23, 2026 updated by: Neuracle Medical Technology(Shanghai) Co.,Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital,Capital Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BCI-assisted ARAT grasp response rate
Time Frame: 3 months post-operation
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
Time Frame: Immediately post-implantation, and at 3-, and 6-months post-operation.
Immediately post-implantation, and at 3-, and 6-months post-operation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ISNCSCI Score of the Participant
Time Frame: Baseline, and at 3-, and 6-months post-operation.
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
Time Frame: 2-, and 6-months post-operation
The investigator completes the ARAT (Action Research Arm Test) scoring form.
2-, and 6-months post-operation
ARAT Score
Time Frame: Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).
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
Time Frame: Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.
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
Time Frame: 2-, 3-, and 6-months post-operation.
Subjects will complete the Subject Device Performance Evaluation Questionnaire.
2-, 3-, and 6-months post-operation.
Device Impedance
Time Frame: 1, 2-, 3-, and 6-months post-operation.
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
Time Frame: 2-, 3-, and 6-months post-operation.
Calculate the total device usage time per month for each participant.
2-, 3-, and 6-months post-operation.
Participant Quality of Life Score
Time Frame: Baseline, and at 2-, 3-, and 6-months post-operation.
Assessment Method: Participants complete the "Quality of Life Questionnaire"
Baseline, and at 2-, 3-, and 6-months post-operation.
Subject Satisfaction Rating
Time Frame: 2-, 3-, and 6-months post-operation.
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
Time Frame: 1-, 2-, 3-, and 6-months post-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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neuracle Medical Technology(Shanghai) Co.,Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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