Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NEO.
- Who it may be relevant to
- Registry conditions: Tetraplegia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Overview
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.
Detailed 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.
Interventions
- Device NEO
Subjects will be implanted with the NEO device.
Primary outcome measures
- Adverse Events [Time frame: 12 months after implantation]
Secondary outcome measures (4)
- BCI performance classification accuracy [Time frame: 3, 6, 12 months after implantation]
- BCI performance by bit rate [Time frame: 3, 6, 12 months after implantation]
- Hours use of the implantable neural acquisitor & stimulator (NEO) per month [Time frame: 3, 6, 12 months after implantation]
- Patient/caregiver satisfaction [Time frame: 3, 6, 12 months after implantation]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 4 centers
- Chinese PLA General Hospital — Beijing
- Xuanwu Hospital，Capital Medical University — Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing
- Huashan Hospital Affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT05920174 · FABRK202301