Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Recruiting now · Not applicable
Conditions studied: Tetraplegia
In brief
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
Key facts
- Study ID
- NCT05920174
- Run by
- Neuracle Medical Technology(Shanghai) Co.,Ltd.
- People needed
- 9
- Starts
- 2023-10-17
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-12-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged between 18 and 80 years of age;
- Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
- After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
- The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
- The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
You may not qualify if…
- Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
- Combined with progressive neurological disease；
- Combined with surgical contraindications identified by surgeons and anesthesiologists;
- Participating in other clinical trials;
- Other conditions deemed inappropriate by investigators and medical staff.
Where it is running
- Xuanwu Hospital，Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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