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Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

Study acronym: HemON
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Jan 31, 2027 to Dec 31, 2030v6
  2. Secondary endpoints: 4 to 3v5
  3. Primary and study completion dates: Jul 31, 2024 to Jan 31, 2027
    • Enrollment target: 16 to 20
    • Secondary endpoints: details revised at 4 of 4 entries
    v4
  4. Secondary endpoints: details revised at 1 of 4 entries
    • Eligibility criteria expanded, about 5 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 15, 2021 to Nov 29, 2021
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.
Trial Details
NCT Number NCT05111093
Lead Sponsor Ecole Polytechnique Fédérale de Lausanne
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Spinal Cord Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov