Research on Wireless Brain Implant System for General Control of External Devices
NCT ID: NCT06829212
Last Updated: 2025-03-13
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
4 participants
INTERVENTIONAL
2025-03-31
2027-02-28
Brief Summary
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WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
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Detailed Description
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The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Implantation
Implantation of the WRS64
WRS
WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).
Interventions
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WRS
WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
* Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
* Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
* Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
Exclusion Criteria
* Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
* Unable to tolerate anesthesia or surgery.
* Severe neurological disorders or brain injury leading to significant dysfunction.
* Scalp conditions that may impair wound healing.
* Acute or severe infections.
* Cognitive impairment or psychiatric disorders.
* Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
* Life expectancy under 1 year.
* Drug or alcohol abuse.
* Pregnant, breastfeeding, or planning pregnancy during the study.
* Other conditions deemed unsuitable by the investigator.
18 Years
80 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Shanghai StairMed Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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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Other Identifiers
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2024-1325
Identifier Type: OTHER
Identifier Source: secondary_id
PI2302-CL-01-001
Identifier Type: -
Identifier Source: org_study_id
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