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Recruiting NCT05111093

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

Trial Parameters

Condition Spinal Cord Injuries
Sponsor Ecole Polytechnique Fédérale de Lausanne
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-11-29
Completion 2030-12-31
Interventions
ARC-IM Investigational System implantation

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 18 years of age or older * Must provide and sign the Informed Consent prior to any study related procedures * Spinal cord injury lesion level between C3 and T6 (inclusive) * SCI ≥ 1month * Confirmed orthostatic hypotension * Stable medical, physical and psychological condition as considered by the investigators * Able to understand and interact with the study team in French or English * Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Exclusion Criteria: * SCI related to a neurodegenerative disease * Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery * The inability to withhold antiplatelet/anticoagulation agents perioperatively * History of myocardial infarction or cerebrovascular event within the past 6 months * Other conditions that would make the subject unable to participate in testing in the judgement of the investigators * Clinically significant mental

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