Health TrialsbyHealthPanel

Research on Wireless Brain Implant System for General Control of External Devices

ConditionsComplete or Incomplete Paraplegia/quadriplegiaSpinal Cord InjuryBrainstem StrokeAmyotrophic Lateral SclerosisBilateral Upper Limb Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai StairMed Technology Co., Ltd.

About this trial

The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-80 years (inclusive), any gender.

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.

Disqualifiers

Previous implantation of metal objects or devices (except dental implants or non-impacting implants).

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • WRS

    Device

    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).

Treatment groups

4 Participants
are divided into 1 treatment group
Group A: ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Device-Related Adverse Events (AE)

Time frame
Through study completion, an average of 7 months

Secondary outcomes

1

Adverse Events

Time frame
Through study completion, an average of 7 months
2

Serious Adverse Event

Time frame
Through study completion, an average of 7 months
3

BPS

Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size.

Time frame
At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
4

Usage Time (hours/month)

The amount of time the subject uses the experimental device each month.

Time frame
At an average of 5 to 7 months after implantation, during the follow-up phases.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai StairMed Technology Co., Ltd.

Lead sponsor

Huashan Hospital

Collaborator

Source ClinicalTrials.gov
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