Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
NCT ID: NCT05920174
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
9 participants
INTERVENTIONAL
2023-10-17
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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single
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.
NEO
Subjects will be implanted with the NEO device.
Interventions
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NEO
Subjects will be implanted with the NEO device.
Eligibility Criteria
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Inclusion Criteria
2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
Exclusion Criteria
2. Combined with progressive neurological disease；
3. Combined with surgical contraindications identified by surgeons and anesthesiologists;
4. Participating in other clinical trials;
5. Other conditions deemed inappropriate by investigators and medical staff.
18 Years
80 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Beijing Tiantan Hospital
OTHER
Chinese PLA General Hospital
OTHER
Huashan Hospital
OTHER
Neuracle Medical Technology(Shanghai) Co.,Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xinguang Yu, Ph.D
Role: primary
Guoguang Zhao, Ph.D
Role: primary
Wang Jia, Ph.D
Role: primary
Liang Chen, Ph.D
Role: primary
Other Identifiers
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FABRK202301
Identifier Type: -
Identifier Source: org_study_id