A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety

Sponsor
NeuroXess Technology (shanghai) Co.,Ltd.
Study ID
NCT07720882
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injury

Eligibility Criteria

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

Interventions

  • "Triple-F" BCI — DEVICE
    Subjects will undergo implantation of the "Triple-F" BCI and receive standardized brain-computer interface training postoperatively, including training with brain-controlled pneumatic gloves. Follow-up visits will be scheduled at 1, 2, 3 and 6 months after implantation.

Study Details

This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2027
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: "Triple-F" BCI
    Experimental: Implantation of the "Triple-F" BCI

Primary Outcome Measure

BCI-assisted ARAT response rate (at 3 months postoperatively) [ Time Frame: 3 months post-operation ]

Central Contacts

Related Studies