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

May 26, 2025 updated by: Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • CHUV
        • Contact:
          • Jocelyne Dr Bloch, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: all participants
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
Device: ARC-IM Investigational System implantation
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System
Time Frame: Throughout study, an average of 26 months
Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension
Throughout study, an average of 26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthostatic head-up tilt test (hemodynamic stability assessment)
Time Frame: Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation
Participant begin by resting in the supine position during which baseline measures are performed. Thereafter, participant is passively moved to upright position using a tilt-table and kept in this position for a maximum of 10 minutes. This test will be performed with and without ARC-IM Therapy. Beat by beat blood pressure is monitored and catecholamine concentrations in the plasma are measured during the tilt-test.
Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation
Modified Ashworth Scale (MAS) (spasticity assessment)
Time Frame: Baseline ; at 1 - 13 months after the implantation

Participants' upper and lower limb spasticity levels (6 points nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. This test will be performed with and without ARC-IM Therapy.

Scores range from 0 to 5 (0, 1, 1+, 2, 3, 4, 5) with higher scores indicating higher spasticity.
Baseline ; at 1 - 13 months after the implantation
SCIM III (daily life performance assessment)
Time Frame: Baseline ; at 1 - 6.5 - 13 months after the implantation
The Spinal Cord Independence Measure (SCIM) is a disability score to assess functional activity in participants. Function is assessed in 3 areas of function: self-care (0-20), respiration and sphincter management (0-40) and mobility (0-40). Total score ranges between 0-100, with higher scores reflecting greater functional ability
Baseline ; at 1 - 6.5 - 13 months after the implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Investigators

  • Principal Investigator: Jocelyne Bloch, MD, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HemON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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