Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study

Sponsor
Shanghai StairMed Technology Co., Ltd.
Study ID
NCT07603752
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • WRS — DEVICE
    WRS is a minimally invasive, wireless brain-machine interface system

Study Details

This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.

Key Dates

First listed
May 22, 2026
Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Implantation of the WRS

Primary Outcome Measure

success rate of brain-controlled tasks [ Time Frame: 3 months post-operation ]

Central Contacts

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