Evaluating a device to help patients with motor disabilities control external equipment

A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

This study is testing a new device that helps people with motor disabilities, like tetraplegia, control things like wheelchairs and robotic arms using their brain signals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Neuracle Medical Technology(Shanghai) Co.,Ltd. (Industry-sponsored)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT05920174 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of an implantable neural acquisitor and stimulator system designed for patients with motor disabilities, specifically those with tetraplegia. Utilizing brain-computer interface technology, the system allows patients to control external devices such as wheelchairs and robotic arms using their brain signals. The study will include patients diagnosed with complete or incomplete quadriplegia due to various neurological conditions, ensuring they have a functional brain motor-related cortex. Participants will be monitored for their ability to use the device effectively and safely over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with stable complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, or motor neuron disorders.

Not a fit: Patients with progressive neurological diseases or significant visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this technology could significantly enhance the quality of life for patients with motor disabilities by providing them greater independence and control over their environment.

How similar studies have performed: While the approach of using brain-computer interfaces is gaining traction, this specific application in motor disabilities is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 80 years of age;
2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.

Exclusion Criteria:

1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
2. Combined with progressive neurological disease；
3. Combined with surgical contraindications identified by surgeons and anesthesiologists;
4. Participating in other clinical trials;
5. Other conditions deemed inappropriate by investigators and medical staff.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Xuanwu Hospital，Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Tao Liu, Master

Conditions Tetraplegia