Status:
NOT_YET_RECRUITING
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Lead Sponsor:
Shanghai StairMed Technology Co., Ltd.
Conditions:
Quadriplegia
Amputations
Eligibility:
All Genders
18-65 years
Phase:
NA
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,...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06944834
Start Date
April 1 2025
End Date
April 1 2027
Last Update
April 25 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China, 710038