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

Sponsor
Ecole Polytechnique Fédérale de Lausanne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05111093
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
32
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: ARC-IM Investigational System implantation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  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 [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 Outcome Measures

  1. Orthostatic head-up tilt test (hemodynamic stability assessment) [Baseline ; at 1 - 6.5 - 13 - 19.5 - 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. Trunk stability measurement (trunk control assessment) [Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation]

    The participant is asked to perform a systematic set of reaching movements, balance and posture tasks while seated freely (without a back-rest). Each task is repeated and pressure, force, kinetic and kinematic data is recorded together with video acquisitions. Addtionally, the participant's static stability is perturbed and magnitude of balance response and time to recover stability are recorded.

  3. Modified Ashworth Scale (MAS) (spasticity assessment) [Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 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.

  4. SCIM III (daily life performance assessment) [Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age 18 to 70 years old

  • 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 non-vesical injections in the previous 3 months

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHUV Lausanne Vaud Switzerland 1011

Sponsors and Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

Investigators

  • Principal Investigator: Jocelyne Bloch, MD, CHUV

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jocelyne Bloch, Prof., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT05111093
Other Study ID Numbers:
  • HemON
First Posted:
Nov 8, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jocelyne Bloch, Prof., Centre Hospitalier Universitaire Vaudois
Spinal Cord Injury
Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries

Study Results

No Results Posted as of May 6, 2022