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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEcole Polytechnique Fédérale de Lausanne

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ARC-IM Investigational System implantation

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ecole Polytechnique Fédérale de Lausanne

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Sponsor institution