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

NCT06944834 | Not Yet Recruiting

• 2 other identifiers: PI2302-CL-01-002JJ202503-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  The incidence of adverse events associated with the device or surgical procedure

  Within 6 months after implantation

Secondary Outcomes (9)

• WRS Efficacy Assessment- Accuracy

  6 months after the implantation

• WRS Efficacy Assessment- Path efficiency

  6 months after the implantation

• WRS Efficacy Assessment- Time consumption

  6 months after the implantation

• Neurological Recovery Assessment

  3, 15, 30, 90, 180 days after implantation

• Changes in Quality of Life

  3, 15, 30, 90, 180 days after implantation

Study Arms (1)

Implantation of the WRS64

EXPERIMENTAL

Implantation of the device and follow-up

Device: Implant

Interventions

Implant DEVICE

Implantation of the device and follow-up

Implantation of the WRS64

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai StairMed Technology Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Brain Stem Infarctions

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Central Study Contacts

Stairmed Clinical team

CONTACT

+86 021-80510178; kongcen@stairmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)