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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ARC-IM Investigational System implantation
Sponsored by
Ecole Polytechnique Fédérale de Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all participants

Arm Description

All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)

Outcomes

Primary Outcome Measures

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
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

Orthostatic head-up tilt test (hemodynamic stability assessment)
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.
Trunk stability measurement (trunk control assessment)
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.
Modified Ashworth Scale (MAS) (spasticity assessment)
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.
SCIM III (daily life performance assessment)
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

Full Information

First Posted
November 1, 2021
Last Updated
September 30, 2022
Sponsor
Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT05111093
Brief Title
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Acronym
HemON
Official Title
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ecole Polytechnique Fédérale de Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all participants
Arm Type
Experimental
Arm Description
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
Intervention Type
Device
Intervention Name(s)
ARC-IM Investigational System implantation
Intervention Description
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Throughout study, an average of 26 months
Secondary Outcome Measure Information:
Title
Orthostatic head-up tilt test (hemodynamic stability assessment)
Description
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.
Time Frame
Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation
Title
Trunk stability measurement (trunk control assessment)
Description
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.
Time Frame
Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation
Title
Modified Ashworth Scale (MAS) (spasticity assessment)
Description
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.
Time Frame
Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation
Title
SCIM III (daily life performance assessment)
Description
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
Time Frame
Baseline ; at 1 - 6.5 - 13 - 19.5 - 26 months after the implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregoire Courtine, Prof
Phone
+41 21 69 30762
Email
gregoire.courtine@epfl.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyne Bloch, MD
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyne Dr Bloch, Prof. Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28967294
Citation
Phillips AA, Squair JW, Sayenko DG, Edgerton VR, Gerasimenko Y, Krassioukov AV. An Autonomic Neuroprosthesis: Noninvasive Electrical Spinal Cord Stimulation Restores Autonomic Cardiovascular Function in Individuals with Spinal Cord Injury. J Neurotrauma. 2018 Feb 1;35(3):446-451. doi: 10.1089/neu.2017.5082. Epub 2017 Nov 21.
Results Reference
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25962761
Citation
Phillips AA, Krassioukov AV. Contemporary Cardiovascular Concerns after Spinal Cord Injury: Mechanisms, Maladaptations, and Management. J Neurotrauma. 2015 Dec 15;32(24):1927-42. doi: 10.1089/neu.2015.3903. Epub 2015 Sep 1.
Results Reference
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PubMed Identifier
27221275
Citation
Squair JW, Phillips AA, Harmon M, Krassioukov AV. Emergency management of autonomic dysreflexia with neurologic complications. CMAJ. 2016 Oct 18;188(15):1100-1103. doi: 10.1503/cmaj.151311. Epub 2016 May 24. No abstract available.
Results Reference
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PubMed Identifier
24473484
Citation
Phillips AA, Warburton DE, Ainslie PN, Krassioukov AV. Regional neurovascular coupling and cognitive performance in those with low blood pressure secondary to high-level spinal cord injury: improved by alpha-1 agonist midodrine hydrochloride. J Cereb Blood Flow Metab. 2014 May;34(5):794-801. doi: 10.1038/jcbfm.2014.3. Epub 2014 Jan 29.
Results Reference
background
PubMed Identifier
25093677
Citation
Phillips AA, Elliott SL, Zheng MM, Krassioukov AV. Selective alpha adrenergic antagonist reduces severity of transient hypertension during sexual stimulation after spinal cord injury. J Neurotrauma. 2015 Mar 15;32(6):392-6. doi: 10.1089/neu.2014.3590. Epub 2014 Dec 5.
Results Reference
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PubMed Identifier
24436297
Citation
Phillips AA, Krassioukov AV, Ainslie PN, Warburton DE. Perturbed and spontaneous regional cerebral blood flow responses to changes in blood pressure after high-level spinal cord injury: the effect of midodrine. J Appl Physiol (1985). 2014 Mar 15;116(6):645-53. doi: 10.1152/japplphysiol.01090.2013. Epub 2014 Jan 16.
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PubMed Identifier
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Citation
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Citation
Phillips AA, Krassioukov AV, Ainslie PN, Warburton DE. Baroreflex function after spinal cord injury. J Neurotrauma. 2012 Oct 10;29(15):2431-45. doi: 10.1089/neu.2012.2507. Epub 2012 Sep 20.
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Citation
Courtine G, Gerasimenko Y, van den Brand R, Yew A, Musienko P, Zhong H, Song B, Ao Y, Ichiyama RM, Lavrov I, Roy RR, Sofroniew MV, Edgerton VR. Transformation of nonfunctional spinal circuits into functional states after the loss of brain input. Nat Neurosci. 2009 Oct;12(10):1333-42. doi: 10.1038/nn.2401. Epub 2009 Sep 20.
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Citation
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PubMed Identifier
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Citation
Harkema SJ, Wang S, Angeli CA, Chen Y, Boakye M, Ugiliweneza B, Hirsch GA. Normalization of Blood Pressure With Spinal Cord Epidural Stimulation After Severe Spinal Cord Injury. Front Hum Neurosci. 2018 Mar 8;12:83. doi: 10.3389/fnhum.2018.00083. eCollection 2018.
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PubMed Identifier
29867586
Citation
Aslan SC, Legg Ditterline BE, Park MC, Angeli CA, Rejc E, Chen Y, Ovechkin AV, Krassioukov A, Harkema SJ. Epidural Spinal Cord Stimulation of Lumbosacral Networks Modulates Arterial Blood Pressure in Individuals With Spinal Cord Injury-Induced Cardiovascular Deficits. Front Physiol. 2018 May 18;9:565. doi: 10.3389/fphys.2018.00565. eCollection 2018.
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Citation
Squair JW, Gautier M, Mahe L, Soriano JE, Rowald A, Bichat A, Cho N, Anderson MA, James ND, Gandar J, Incognito AV, Schiavone G, Sarafis ZK, Laskaratos A, Bartholdi K, Demesmaeker R, Komi S, Moerman C, Vaseghi B, Scott B, Rosentreter R, Kathe C, Ravier J, McCracken L, Kang X, Vachicouras N, Fallegger F, Jelescu I, Cheng Y, Li Q, Buschman R, Buse N, Denison T, Dukelow S, Charbonneau R, Rigby I, Boyd SK, Millar PJ, Moraud EM, Capogrosso M, Wagner FB, Barraud Q, Bezard E, Lacour SP, Bloch J, Courtine G, Phillips AA. Neuroprosthetic baroreflex controls haemodynamics after spinal cord injury. Nature. 2021 Feb;590(7845):308-314. doi: 10.1038/s41586-020-03180-w. Epub 2021 Jan 27.
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Darrow D, Balser D, Netoff TI, Krassioukov A, Phillips A, Parr A, Samadani U. Epidural Spinal Cord Stimulation Facilitates Immediate Restoration of Dormant Motor and Autonomic Supraspinal Pathways after Chronic Neurologically Complete Spinal Cord Injury. J Neurotrauma. 2019 Aug 1;36(15):2325-2336. doi: 10.1089/neu.2018.6006. Epub 2019 Mar 6.
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Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

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