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

Ecole Polytechnique Fédérale de Lausanne

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Device: ARC-IM Investigational System implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05111093

HemON

Details and patient eligibility

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.