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RECRUITING
NCT07720882
NA

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.

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Multicenter, Single-Arm Target Value Clinical Trial to Evaluate the Efficacy and Safety of Implantable Brain-Computer Interface Hand Motor Function Compensation System for Upper-Limb Functional Replacement in Tetraplegic Patients With Spinal Cord Injury

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-07-07

Completion Date

2027-04-30

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DEVICE

"Triple-F" BCI

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.

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China