Actively Recruiting
A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Led by Neuracle Medical Technology(Shanghai) Co.,Ltd. · Updated on 2024-12-05
9
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an implantable neural acquisitor and stimulator system called NEO in patients with motor disabilities such as complete or incomplete quadriplegia caused by spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis, and other motor neuron disorders. This technology uses brain-computer interface methods to help patients control external devices like wheelchairs, robotic arms, and apps, aiming to improve their quality of life. Participants will receive the NEO device implanted to connect their brain signals to various external aids. The study focuses on monitoring the safety of the device over 12 months after implantation and assessing how well the brain-computer interface performs at 3, 6, and 12 months. Researchers will also track the monthly usage hours of the device and gather satisfaction feedback from patients and caregivers. During the study, participants will undergo neurological assessments and regular evaluations to monitor adverse events and device performance. Outcome measures include brain-computer interface accuracy, bit rate, usage duration, and satisfaction surveys at multiple timepoints up to one year. The trial is designed to carefully observe the effects and usability of the implanted system in adults aged 18 to 80 with stable motor disabilities.
CONDITIONS
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis, or other motor neuron disorders
- Functional brain motor-related cortex without obvious organic or functional disease
- Diagnosed with the above conditions for at least 12 months and stable for at least 6 months after standard treatment
- Normal cognitive function, good compliance, and voluntary participation in the clinical trial
You will not qualify if you...
- Visual impairment that makes extended viewing of a computer monitor difficult even with corrective lenses
- Progressive neurological disease
- Surgical contraindications identified by surgeons or anesthesiologists
- Participation in other clinical trials
- Other conditions deemed inappropriate by investigators and medical staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the NEO device, an implantable neural acquisitor and stimulator system designed to assist with motor disability.
1 implantation visit (in-person)
Duration - 12 months
Participants are monitored for safety and efficacy of the implanted device and receive regular assessments of device performance and satisfaction.
Visits at 3, 6, and 12 months after implantation (in-person)
Trial Site Locations
Total: 4 locations
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Not Yet Recruiting
2
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
3
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
4
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
T
Tao Liu, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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