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

Study acronym: BCI4STROKE-Arm
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment openedv2 Show 4 more changesShow less
    • Study completion moved earlier from Jun 30, 2031 to Apr 8, 2031
    • Study sites: 0 to 1
    • Primary completion date: Mar 30, 2029 to Apr 8, 2029
    • Start date changed from estimate of Mar 30, 2026 to Apr 8, 2026
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07477613
Lead Sponsor University Hospital, Grenoble
Collaborators: French Alternative Energies and Atomic Energy Commission (CEA), Grenoble
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov