NCT06944834Not yet recruiting
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- Apr 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.
- Diseases
- Stroke
- NCT number
- NCT06944834
What you commit to
- Study type: Interventional
- Planned participants: 5
- From Apr 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
- Other conditions considered unsuitable by investigators or medical staff.
Other
- Morbid obesity (BMI \>40);
- Current participation in other clinical trials;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.