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A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation

NCT06944834 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-04-25

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.

Conditions

  • Quadriplegia
  • Amputations
  • Spinal Cord Injuries (SCI)
  • Brainstem Stroke

Interventions

DEVICE

Implant

Implantation of the device and follow-up

Sponsors & Collaborators

  • Shanghai StairMed Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944834 on ClinicalTrials.gov