RecruitingNot ApplicableNCT05920174

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

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

Sponsor

Neuracle Medical Technology(Shanghai) Co.,Ltd.

Enrollment

9 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

tetraplegia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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.

Exclusion Criteria5

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.

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