NCT07477613

Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The clinical investigation will take place in three phases: * A pre-selection/selection phase to ensure that the patient (lesion, symptoms, ability of our tools to detect your movement intentions, etc.) is suitable for a six-month intensive rehabilitation program using Brain-Machine Interface. * A second phase, consisting of implementing the intensive rehabilitation program, first in the traditional manner, without the Brain-Machine Interface (2 to 5 weeks), then, after implantation, with the Brain-Machine Interface (6 months). * During the third phase, only follow-up visits will be scheduled to ensure the longevity of the implants and the maintenance of the motor progress achieved through rehabilitation.

Detailed description

The BCI4STROKE-Arm clinical trial aims to demonstrate the proof of concept of innovative neurorehabilitation protocols in stroke patients based on the use of neuroprostheses. The objective is to define and evaluate rehabilitation protocols in chronic patients 6 to 18 months after a disabling stroke, promoting neuroplasticity processes through the use of the WIMAGINE neuroprosthesis and brain signal decoding algorithms. This brain-machine interface (BCI) based on the WIMAGINE electrocorticographic (ECoG) measurement implant will be used to control hand rehabilitation devices (functional electrical stimulation, robotic orthosis, and video observation therapy device) as part of the REHABCI system. Patients will follow a six-month intensive rehabilitation program (between three and five days per week) based on the use of this REHABCI system.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	BCI	WIMAGINE

Timeline

• Start date: 2026-03-30
• Primary completion: 2029-03-30
• Completion: 2031-06-30
• First posted: 2026-03-17
• Last updated: 2026-03-17