Using electrical stimulation to improve blood flow and trunk control in spinal cord injury patients
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
This study is testing a new electrical stimulation therapy to see if it can help people with spinal cord injuries improve their blood flow and trunk control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT05111093 on ClinicalTrials.gov |
What this trial studies
The HemON study evaluates the safety and preliminary efficacy of ARC-IM Therapy, which involves the implantation of an investigational system for epidural electrical stimulation. This therapy aims to enhance hemodynamic management and trunk control in individuals with sub-acute or chronic spinal cord injuries, specifically those experiencing orthostatic hypotension. Participants must have sustained a spinal cord injury between the C3 and T6 vertebrae and be at least one month post-injury. The study will assess the impact of this intervention on their overall stability and control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with spinal cord injuries between C3 and T6 who have been diagnosed with orthostatic hypotension.
Not a fit: Patients with spinal cord injuries related to neurodegenerative diseases or those with recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve blood flow regulation and trunk control for patients with spinal cord injuries.
How similar studies have performed: While similar approaches have been explored, this specific application of epidural electrical stimulation for hemodynamic stability in spinal cord injury patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lausanne, Canton of Vaud
- Chuv — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jocelyne Bloch, MD — Chuv
- Study coordinator: Gregoire Courtine, Prof
- Email: gregoire.courtine@epfl.ch
- Phone: +41 21 69 30762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.