A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation (STAIR)

April 17, 2025 updated by: Shanghai StairMed Technology Co., Ltd.
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.

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.
5

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
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • The Second Affiliated Hospital of Air Force Medical 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:

  • Adults aged 18-65 years;
  • Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
  • Normal motor cortex function confirmed by neurological assessment;
  • Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
  • Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
  • Expected lifespan ≥12 months;
  • Normal cognitive function;
  • Normal hearing and vision, or corrected vision to normal with standard lenses;
  • Patients with stable caregivers;
  • Willing to sign informed consent and able to comply with follow-up requirements.

Exclusion Criteria:

  • Patients with neuropsychiatric disorders or psychological impairments;
  • Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
  • History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
  • History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
  • Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
  • Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;
  • Morbid obesity (BMI >40);
  • Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
  • Current participation in other clinical trials;
  • Other conditions considered unsuitable by investigators or medical staff.

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: Device Feasibility
  • 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 WRS64
Implantation of the device and follow-up
Device: Implant
Implantation of the device and follow-up

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
Adverse events
Time Frame: Within 6 months after implantation
The incidence of adverse events associated with the device or surgical procedure
Within 6 months after implantation

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
WRS Efficacy Assessment- Accuracy
Time Frame: 6 months after the implantation
Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better.
6 months after the implantation
WRS Efficacy Assessment- Path efficiency
Time Frame: 6 months after the implantation
Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance.
6 months after the implantation
WRS Efficacy Assessment- Time consumption
Time Frame: 6 months after the implantation
Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance.
6 months after the implantation
Neurological Recovery Assessment
Time Frame: 3, 15, 30, 90, 180 days after implantation
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status.
3, 15, 30, 90, 180 days after implantation
Changes in Quality of Life
Time Frame: 3, 15, 30, 90, 180 days after implantation
Variations in the MOS item short from health survey (SF-36) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). The score values directly reflect health status - higher scores indicate better functional outcomes and superior quality of life.
3, 15, 30, 90, 180 days after implantation
Changes in Cognitive Performance
Time Frame: 3, 15, 30, 90, 180 days after implantation
Variations in Montreal Cognitive Assessment (MoCA) scores scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Elevated scores are associated with improved cognitive function.
3, 15, 30, 90, 180 days after implantation
Changes in Psychological Status
Time Frame: 3, 15, 30, 90, 180 days after implantation
Variations in Patient Health Questionnaire (PHQ-9) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
3, 15, 30, 90, 180 days after implantation
Changes in Anxiety Status
Time Frame: 3, 15, 30, 90, 180 days after implantation
Variations in Hamilton Anxiety Rating Scale (HAMA) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
3, 15, 30, 90, 180 days after implantation
Changes in Depression Status
Time Frame: 3, 15, 30, 90, 180 days after implantation
Variations in Hamilton Depression Rating Scale (HAMD) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
3, 15, 30, 90, 180 days after implantation

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.

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 (Estimated)

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 1, 2025

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.
April 1, 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.
April 1, 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).
April 8, 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.
April 17, 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.
April 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.
April 25, 2025

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.
April 17, 2025

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.
March 1, 2025

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.
  • PI2302-CL-01-002
  • JJ202503-01 (Other Identifier: IEC of Institution for National Drug Clinical Trials, Tangdu Hospital, Fourth Military Medical 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

product manufactured in and exported from the U.S.

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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