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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    16
  • sponsor
    Ecole Polytechnique Fédérale de Lausanne
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Updated on 24 October 2022
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electrical stimulation
spinal cord
spinal cord disorder

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.

Details
Condition Spinal Cord Injuries
Treatment ARC-IM Investigational System implantation
Clinical Study IdentifierNCT05111093
SponsorEcole Polytechnique Fédérale de Lausanne
Last Modified on24 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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