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

NCT ID: NCT06944834

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-04-30

Brief Summary

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.

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.

Conditions

Quadriplegia; Amputations; Spinal Cord Injuries (SCI); Brainstem Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Implantation of the WRS64

Implantation of the device and follow-up

Group Type: EXPERIMENTAL

Implant

Intervention Type: DEVICE

Implantation of the device and follow-up

Interventions

Implant

Implantation of the device and follow-up

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai StairMed Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Stairmed Clinical team

Role: CONTACT

kongcen@stairmed.com

+86 021-80510178

Facility Contacts

Ruili Zhang, Ph.D

Role: primary

zhang.ruili@qq.com

+86 29 8471 7761

Other Identifiers

JJ202503-01

Identifier Type: OTHER

Identifier Source: secondary_id

PI2302-CL-01-002

Identifier Type: -

Identifier Source: org_study_id