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

Launched by ECOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE · Nov 1, 2021

Keywords

ClinConnect Summary

The HemON study is exploring a new treatment called ARC-IM Therapy, which involves using Epidural Electrical Stimulation to help people with spinal cord injuries (SCI) improve their body stability and control their trunk movement. This study specifically focuses on individuals who have had a spinal cord injury for at least one month and experience a condition called orthostatic hypotension, which causes a sudden drop in blood pressure when standing up. The goal is to determine if this therapy is safe and effective for individuals with injuries at specific levels of the spine, from C3 to T6.

To participate in this study, individuals must be 18 years or older, able to understand English or French, and have a confirmed spinal cord injury at the appropriate levels. They should also be in stable health and willing to attend all scheduled appointments. Participants will receive monitoring and care throughout the study to ensure their safety. It’s important to note that certain conditions or recent health events may disqualify someone from joining, like recent surgeries or serious health issues. Overall, this trial aims to provide hope for improved health and quality of life for those affected by spinal cord injuries.

Gender

ALL

Eligibility 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.