NEO
DeviceSubjects will be implanted with the NEO device.
NCT Number: NCT05920174
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be implanted with the NEO device.
Time frame: 12 months after implantation
Number of Participants With the device-Related Adverse Events
Time frame: 3, 6, 12 months after implantation
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by classification accuracy (percentage of patient correct commands to overall number of detected commands)
Time frame: 3, 6, 12 months after implantation
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by bit rate (number of commands per minute).
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
The evaluation of patient and caregiver satisfaction will be carried out using a "satisfaction questionnaire" designed by the researcher (rated from Level 1 to 5) on their feelings (patient/caregiver) of use.
Contact information is provided by the study sponsor or research team.
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Industry
A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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