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An Early Feasibility Study of the ReHAB System

Study acronym: ReHAB
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 5 months later Mar 1, 2027 → Aug 1, 2029
See other at-risk trials from University Hospitals Cleveland Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 1, 2027 to Aug 1, 2029
    • Sponsor changed: Jennifer Sweet, MD to University Hospitals Cleveland Medical Center
    v14
  2. Primary and study completion dates: Mar 1, 2026 to Mar 1, 2027
    • Site contact updated
    • Publications: 2 to 3
    v13
  3. Primary and study completion dates: Mar 1, 2025 to Mar 1, 2026v12
  4. Lead sponsor: Jonathan Miller, MD to Jennifer Sweet, MDv11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Mar 1, 2024 to Mar 1, 2025v9
  2. 2 versions Re-verified since May 27, 2021, no change to tracked fieldsv7-v8
  3. Site contact updatedv6
  4. Site contact updatedv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2019 to Apr 9, 2019
    • Site details revised
    v4
  6. Start date: May 1, 2019 to Aug 1, 2019v3
  7. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions. The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.
Trial Details
NCT Number NCT03898804
Lead Sponsor University Hospitals Cleveland Medical Center
Conditions
(from sponsor)		 Tetraplegia
Related terms Quadriplegia
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov