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NCT Number: NCT05111093

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

Jocelyne Dr Bloch, Prof. Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARC-IM Investigational System implantation

Device

Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gregoire Courtine, Prof

CONTACT

[email protected]

+41 21 69 30762

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Registry information

Acronym: HemON

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Nov 8, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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