Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study

May 16, 2026 updated by: Shanghai StairMed Technology Co., Ltd.

A Prospective, Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of an Implantable Wireless Brain-machine Interface System in Patients With Spinal Cord Injury

This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.

Study Overview

Status

Status

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

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 (Estimated)

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.
34

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:

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. Aged 18 to 65 years old (inclusive), with no restriction on gender.
  2. Meeting all the following requirements:

(1) Suffering from complete or incomplete tetraplegia secondary to cervical spinal cord injury (C2-C6); (2) Diagnosed in line with the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) issued by the American Spinal Injury Association (ASIA), with neurological injury grade classified as Grade A to Grade C; (3) Having fulfilled the above diagnostic criteria for no less than 12 months; 3. Confirmed by imaging examinations and neurological evaluations that the motor-related cerebral cortex is structurally intact, functionally normal and free of obvious atrophy, organic lesions or functional disorders; 4. Fertile participants must agree to use effective contraception throughout the trial period; 5. Participants, either independently or with caregiver assistance, are willing to follow investigators' guidance, comply with all procedures stipulated in the study protocol and complete all scheduled trial visits as required; 6. Having normal cognitive function with a Mini-Mental State Examination (MMSE) score ≥20 points (excluding three-step commands, writing and drawing items); 7. Elbow flexor muscle strength ≤ Grade 3 assessed by ISNCSCI scale; 8. Being of good compliance, voluntarily participating in the clinical trial and signing the informed consent form.

Exclusion Criteria:

  1. Having received implantation of any metallic objects or devices in the body (e.g., pacemaker, defibrillator, neurostimulator, cochlear implant, electronic devices, drug infusion pumps, etc.), excluding dental metallic implants or other implants confirmed to have no impact on the study.
  2. Long-term use of anticoagulants or antiplatelet drugs prior to screening, with antiplatelet drugs not discontinued for at least 2 weeks before surgery; or suffering from hematological diseases such as aplastic anemia and systemic lupus erythematosus; or having clinically significant abnormal coagulation function during the screening period.
  3. Having contraindications to magnetic resonance imaging (MRI) or being unable to complete MRI examinations for other reasons.
  4. Being assessed by anesthesiologists as intolerant to anesthetic surgery.
  5. Having neurological diseases (e.g., cerebrovascular lesions, intracranial infection, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma leading to severe brain dysfunction or obvious abnormal electroencephalographic signals, as judged by investigators.
  6. Suffering from physical or pathological conditions that may cause failed normal healing of scalp wounds.
  7. Being in the stage of acute infection or suffering from other severe infections.
  8. Having any unstable or severe medical conditions that may interfere with study procedures or confound the evaluation of study endpoints, including previously diagnosed mania, depression, Alzheimer's disease, mood disorders, intellectual disability, other cognitive disorders, severe attention deficit, etc.
  9. Suffering from severe dysfunction of vital organs including heart, lung, liver and kidney: such as severe cardiovascular diseases (e.g., hospitalization or cardiac surgery due to myocardial infarction within 3 months, congestive heart failure, myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm); severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.).
  10. Diagnosed with malignant tumors, autoimmune diseases, peripheral neuropathy, poorly controlled diabetes mellitus, or other severe diseases deemed unsuitable for this clinical trial by investigators.
  11. Severe spasticity, severe neuralgia, or uncontrolled complex regional pain syndrome that hinders participants from completing training sessions.
  12. Spinal cord dysfunction or injury caused by autoimmune disorders.
  13. Having visual impairment that makes it difficult to view display screens for a long time even with standard corrective lenses.
  14. Suffering from infectious diseases such as active pulmonary tuberculosis, viral hepatitis (hepatitis B, hepatitis C), syphilis and AIDS.
  15. Receiving pharmacotherapy or physical therapy affecting the central nervous system before enrollment, and unable to discontinue such treatments after enrollment as assessed by investigators.
  16. Having a history of drug abuse, nicotine dependence or alcohol dependence.
  17. Pregnant or lactating females, or those planning to become pregnant during the study period.
  18. Having participated or currently participating in any drug clinical trial within 90 days prior to enrollment, or any other medical device clinical trial within 30 days prior to enrollment.
  19. Any other conditions deemed inappropriate for participation in this clinical trial by investigators.

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: Implantation of the WRS
Device: WRS
WRS is a minimally invasive, wireless brain-machine interface system

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
success rate of brain-controlled tasks
Time Frame: 3 months post-operation
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control task
3 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
success rate of brain-controlled tasks
Time Frame: 6 months post-operation
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control
6 months post-operation
Brain Control Fluency Index
Time Frame: up to 180 days
up to 180 days
Task Accuracy
Time Frame: up to 180 days
up to 180 days
Device Reliability
Time Frame: up to 180 days
up to 180 days
Device Usage Duration
Time Frame: up to 180 days
up to 180 days
Evaluation of Brain-Controlled Wheelchair
Time Frame: 3 and 6 months post-operation
3 and 6 months post-operation
WHOQOL-BREF
Time Frame: 3 and 6 months post-operation
3 and 6 months post-operation
dIADL
Time Frame: 3 and 6 months post-operation
3 and 6 months post-operation
HADS-A
Time Frame: 3 and 6 months post-operation
3 and 6 months post-operation
PHQ-9
Time Frame: 3 and 6 months post-operation
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.
Shanghai StairMed Technology 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.
Huashan Hospital

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.
April 28, 2026

Primary Completion (Estimated)

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.
January 31, 2027

Study Completion (Estimated)

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.
June 30, 2027

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 12, 2026

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 16, 2026

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 22, 2026

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.
May 22, 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.
May 16, 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, 2026

More Information

Terms related to this study

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.
  • STAIRSUP-001
  • 2026-825 (Other Identifier: Huashan Hospital Institutional Review Board of Fudan University)

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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