Actively Recruiting
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-05-30
20
Participants Needed
1
Research Sites
474 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Spinal cord injury at least 1 month old
- 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
You will not qualify if you...
- Spinal cord injury related to a neurodegenerative disease
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- Inability to withhold antiplatelet or anticoagulation agents around surgery
- History of heart attack or stroke within the past 6 months
- Other conditions that would make participation in testing impossible as judged by investigators
- Clinically significant mental illness as judged by investigators
- Botulinum toxin bladder and non-bladder injections in the 3 months before enrollment
- Presence of significant pressure ulcers
- Recurrent urinary tract infection resistant to antibiotics
- Presence of indwelling baclofen or insulin pump
- Women who are pregnant or breastfeeding; pregnancy test required for women who can become pregnant
- Lack of safe contraception for women able to become pregnant
- Intention to become pregnant during the study
- Other clinically significant diseases (e.g., kidney failure, liver problems, cardiovascular disease)
- Inability to follow study procedures due to language, psychological disorders, or dementia
- Participation in another investigational drug study within 30 days before and during this study
- Enrollment of the investigator, their family, employees, or other dependent persons
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
G
Gregoire Courtine, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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