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

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: Not yet recruiting
• Conditions: Quadriplegia; Spinal Cord Injuries (SCI); Amputations; Brainstem Stroke
• Intervention / Treatment: Device: Implant

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: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stairmed Clinical team; Phone Number: +86 021-80510178; Email: kongcen@stairmed.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • The Second Affiliated Hospital of Air Force Medical University
      • Contact: Ruili Zhang, Ph.D; Phone Number: +86 29 8471 7761; Email: zhang.ruili@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: 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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WRS Efficacy Assessment- Accuracy	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	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	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	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	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	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	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	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	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

• Sponsor: Shanghai StairMed Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Trauma, Nervous System; Spinal Cord Diseases; Ischemia; Stroke; Paralysis; Spinal Cord Injuries; Quadriplegia; Brain Stem Infarctions
• Other Study ID 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