Spinal cord stimulation for low blood pressure and trunk control after spinal cord injury
Tests epidural electrical stimulation in people with spinal cord injury and orthostatic hypotension.
Key facts
- Who runs it
- Ecole Polytechnique Fédérale de Lausanne
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 29 Nov 2021
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional
- Treatments tested
- ARC-IM Investigational System implantation
- Record updated
- 30 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a spinal cord injury between C3 and T6 who have low blood pressure when sitting or standing up (orthostatic hypotension). It tests an implanted spinal stimulation device (ARC-IM).
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Spinal cord injury at level C3 to T6 (inclusive), at least 1 month after the injury. Confirmed orthostatic hypotension. Stable medical, physical and mental condition.
- Earlier treatment
- No botulinum toxin injections (bladder or other) in the 3 months before joining. No investigational drug study in the 30 days before.
Main reasons for not taking part
- Spinal cord injury caused by a neurodegenerative disease
- Heart attack or stroke in the past 6 months
- Unable to stop blood-thinning or antiplatelet drugs around surgery
- Implanted baclofen or insulin pump, or significant pressure ulcers
- Pregnant, breastfeeding, or planning pregnancy
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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
Who cannot take part
- Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- SCI related to a neurodegenerative disease
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- 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
- Recurrent urinary tract infection refractory to antibiotics
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,
- The inability to withhold antiplatelet/anticoagulation agents perioperatively
- Presence of significant pressure ulcers
- 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,
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- all participantsTreatment being tested
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
Treatment: ARC-IM Investigational System implantation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- Plain-language title
- Spinal cord stimulation for low blood pressure and trunk control after spinal cord injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 30 May 2025