NCT05111093 Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
| NCT ID | NCT05111093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-11-29 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-11-29 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 illness in the judgement of the investigators * Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment * Presence of significant pressure ulcers * Recurrent urinary tract infection refractory to antibiotics * Presence of indwelling baclofen or insulin pump * Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, * Lack of safe contraception for women of childbearing capacity, * Intention to become pregnant during the course of the study, * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Contact & Investigator
Jocelyne Bloch, MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT05111093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05111093 currently recruiting?
Yes, NCT05111093 is actively recruiting participants. Contact the research team at gregoire.courtine@epfl.ch for enrollment information.
Where is the NCT05111093 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05111093 clinical trial?
NCT05111093 is sponsored by Ecole Polytechnique Fédérale de Lausanne. The principal investigator is Jocelyne Bloch, MD at CHUV. The trial plans to enroll 20 participants.