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

Neuracle Medical Technology

Status: Enrolling

Conditions: Tetraplegia

Treatments: Device: NEO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05920174

FABRK202301

Details and patient eligibility

About

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.

Full description

To evaluate the safety and efficacy of an implantable neural acquisitor & stimulator system in patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

single

Experimental group

Description:

Patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders). Implantation of NEO device.

Treatment:

Device: NEO