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

ConditionTetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNeuracle Medical Technology(Shanghai) Co.,Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • NEO

Treatment groups

9 Participants
are divided into 1 treatment group

Sponsors and collaborators

Neuracle Medical Technology(Shanghai) Co.,Ltd.

Lead sponsor

Xuanwu Hospital, Beijing

Collaborator

Beijing Tiantan Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

Huashan Hospital

Collaborator