Back to resultsClinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Primary Purpose
Tetraplegia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NEO
Sponsored by
About this trial
This is an interventional other trial for Tetraplegia
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.
Sites / Locations
- Chinese PLA General Hospital
- Xuanwu Hospital，Capital Medical University
- Beijing Tiantan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single
Arm 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.
Outcomes
Primary Outcome Measures
Adverse Events
Number of Participants With the device-Related Adverse Events
Secondary Outcome Measures
BCI performance classification accuracy
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)
BCI performance by bit rate
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by bit rate (number of commands per minute).
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Patient/caregiver satisfaction
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.
Full Information
NCT ID
NCT05920174
First Posted
May 29, 2023
Last Updated
June 16, 2023
Sponsor
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Collaborators
Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05920174
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Official Title
A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuracle Medical Technology(Shanghai) Co.,Ltd.
Collaborators
Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
an implantable neural acquisitor & stimulator system
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
NEO
Intervention Description
Subjects will be implanted with the NEO device.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of Participants With the device-Related Adverse Events
Time Frame
12 months after implantation
Secondary Outcome Measure Information:
Title
BCI performance classification accuracy
Description
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
Title
BCI performance by bit rate
Description
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
Title
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Description
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Time Frame
3, 6, 12 months after implantation
Title
Patient/caregiver satisfaction
Description
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.
Time Frame
3, 6, 12 months after implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Liu, Master
Phone
021-58086056
Email
liutao@neuracle.cn
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Xuanwu Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoguang Zhao, Ph.D
First Name & Middle Initial & Last Name & Degree
Guoguang Zhao, Ph.D
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jia, Ph.D
First Name & Middle Initial & Last Name & Degree
Wang Jia, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
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