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Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury (STIMO HEMO)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Device implantation
Sponsored by
Jocelyne Bloch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring SCI, Spinal Cord Injury, Epidural Spinal Stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 70 years old
  • Able to undergo the informed consent/assent process
  • Radiologically confirmed spinal cord injury
  • Spinal cord injury between C3 and T6
  • Classified with AIS A or B Spinal cord injury
  • Stable medical, physical and psychological condition as considered by Investigators
  • Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
  • Confirmed orthostatic hypotension and autonomic dysreflexia
  • Willing to attend all scheduled appointments

Exclusion Criteria:

  • Patients in an emergency situation
  • 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
  • Other conditions that would make the subject unable to participate in testing in the judgment of the investigators
  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the investigators
  • Clinically significant mental illness in the judgment of the investigators
  • Botulinum toxin injections in the previous 6 months
  • Presence of significant pressure ulcers
  • Recurrent urinary tract infection refractory to antibiotics
  • Current pregnancy
  • Current breastfeeding
  • Known or suspected drug or alcohol abuse
  • Unhealed spinal fractures
  • Presence of indwelling baclofen or insulin pump

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted Epidural Spinal Stimulation

Arm Description

Participants will undergo a surgery for Targeted Epidural Spinal Stimulation (TESS). The neurostimulation system will be used to manage blood pressure instability. Patients will then proceed to one month of an intensive device configuration protocol to configure the TESS settings of their investigational device to regain hemodynamic stability. After the intensive device configuration phase, daily supervised at-home hemodynamic TESS will be tested for 5 sessions per week for two weeks. Thereafter, and up to 10 months post-implant, patients will have a minimum of 5 TESS supported at-home sessions per week and one laboratory visit per month during a long-term at-home hemodynamic TESS phase. Finally, patients will have to undergo additional testing during a configuration of additional TESS programs phase. During this phase TESS configurations for hemodynamic stability, respiratory function, trunk stability and spasticity will be tested.

Outcomes

Primary Outcome Measures

Occurrence of Adverse Events and Serious Adverse Events that are deemed related or possibly related to the study procedure or to the study investigational system, from implant surgery until the end of study.
Investigate the preliminary safety of hemodynamic targeted epidural spinal stimulation (TESS) to modulate pressor responses and manage blood pressure instability in patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension (n=4).

Secondary Outcome Measures

ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)
Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
Spasticity clinical exam using the Modified Ashworth Scale (MAS)
Patient's limb spasticity levels (5-point nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. Scores range from 0 to 4 with higher scores indicating higher spasticity.
Spasticity isokinetic quantification
A dynamometer (Cybex) is used to evaluate the effect of stimulation on spasticity of the hip, knee and ankle. An extension and flexion movement is performed around each joint (dynamometer in isokinetic mode).
Spasticity isokinetic quantification
An extension and flexion movement is performed around each joint. EMG data is recorded through each movement.
Trunk stability
The patient is asked to perform a systematic set of reaching movements while seated freely (without a back-rest). Additionally, the patient is asked to perform a set of movements deemed functionally relevant, for example reaching for an object behind them or picking up an object from the ground. Each movement is repeated and EMG data can be acquired.
Respiratory function evaluation
The respiratory function is evaluated using a spirometer. Volume is recorded.
Respiratory function evaluation
The respiratory function is evaluated using a spirometer. Flow is recorded.
Orthostatic head-up tilt test
Patients begin by resting in the supine position during which a baseline recording is performed. Thereafter, patients will be passively moved to upright position using the tilt-table. Between each experimental condition, the patient will be moved back in supine position to return to baseline. Beat-to-beat blood pressure will be monitored.
Autonomic Dysfunction Following Spinal cord injury (ADFSCI)
The ADFSCI questionnaire is a 24-item self-reported questionnaire. The questionnaire consists of demographics, medications, frequency/severity of symptoms during AD and hypotensive events. Higher scores indicate more severe and more frequent symptoms during AD and hypotensive events.
Quality of Life questionnaire WHOQOL-BREF
The WHOQOL-BREF is a questionnaire used to assess the quality of life. Scores are converted to range between 4-20 or 0-100 and are scaled in a positive direction: higher scores denote higher quality of life.
Completion of a Daily Stimulation Log (DSL) by the patient
The patient will be asked to self-report the use of TESS during the at-home phases. This information will be used to evaluate hemodynamic TESS-supported at-home stimulation sessions and characterize the use of the investigational system at home.

Full Information

First Posted
June 3, 2021
Last Updated
October 16, 2023
Sponsor
Jocelyne Bloch
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1. Study Identification

Unique Protocol Identification Number
NCT04994886
Brief Title
Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
Acronym
STIMO HEMO
Official Title
Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jocelyne Bloch

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 purpose of this study is to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability in patients with chronic cervical or high-thoracic spinal cord injury. The ultimate objective of this feasibility study is to provide preliminary safety and efficacy measures on the ability of the hemodynamic Targeted Epidural Spinal Stimulation (TESS) to ensure the long-term management of hemodynamic instability and reduce the incidence and severity of orthostatic hypotension and autonomic dysreflexia episodes in humans with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, spasticity, trunk stability and quality of life in patients with chronic spinal cord injury will be evaluated.
Detailed Description
The investigators hypothesize that Targeted Epidural Spinal Stimulation (TESS) foreshadows a new era in the hemodynamic management of both acute and chronic SCI. It is envisioned that TESS will become the first-line treatment for hemodynamic instability in people with chronic SCI, where vasopressor agents and compression garments will become second-line treatments behind the precise control of blood pressure achieved with TESS. In this study, the investigators propose to investigate the preliminary safety of hemodynamic TESS to modulate pressor responses and manage blood pressure instability in 4 patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension. The study intervention consists of 8 phases preceded by pre-screening: Screening and enrolment Baseline and pre-implantation assessments Surgery Intensive TESS Configuration phase Daily supervised at-home TESS phase Long-term at-home phase Configuration of additional TESS programs phase End of study Measures will be performed before surgical intervention and at regular intervals during the study. The study will take place at the CHUV (Lausanne, Switzerland). A total of 4 participants will be enrolled in the study and implanted with two lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) and two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic). All participants will undergo the same treatment and procedures. The total duration of the study will be approximately 2 months (up to 10 months/participant).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-site, single-arm, non-blinded, non-randomized, interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted Epidural Spinal Stimulation
Arm Type
Experimental
Arm Description
Participants will undergo a surgery for Targeted Epidural Spinal Stimulation (TESS). The neurostimulation system will be used to manage blood pressure instability. Patients will then proceed to one month of an intensive device configuration protocol to configure the TESS settings of their investigational device to regain hemodynamic stability. After the intensive device configuration phase, daily supervised at-home hemodynamic TESS will be tested for 5 sessions per week for two weeks. Thereafter, and up to 10 months post-implant, patients will have a minimum of 5 TESS supported at-home sessions per week and one laboratory visit per month during a long-term at-home hemodynamic TESS phase. Finally, patients will have to undergo additional testing during a configuration of additional TESS programs phase. During this phase TESS configurations for hemodynamic stability, respiratory function, trunk stability and spasticity will be tested.
Intervention Type
Procedure
Intervention Name(s)
Device implantation
Intervention Description
The intervention involves the insertion of 2 lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) epidurally over the dorsal aspect of the spinal cord through 2 laminectomies and two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic) in the abdomen of the participant.
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events and Serious Adverse Events that are deemed related or possibly related to the study procedure or to the study investigational system, from implant surgery until the end of study.
Description
Investigate the preliminary safety of hemodynamic targeted epidural spinal stimulation (TESS) to modulate pressor responses and manage blood pressure instability in patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension (n=4).
Time Frame
From implantation through study completion, an average of 7 months
Secondary Outcome Measure Information:
Title
ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)
Description
Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Spasticity clinical exam using the Modified Ashworth Scale (MAS)
Description
Patient's limb spasticity levels (5-point nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. Scores range from 0 to 4 with higher scores indicating higher spasticity.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Spasticity isokinetic quantification
Description
A dynamometer (Cybex) is used to evaluate the effect of stimulation on spasticity of the hip, knee and ankle. An extension and flexion movement is performed around each joint (dynamometer in isokinetic mode).
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Spasticity isokinetic quantification
Description
An extension and flexion movement is performed around each joint. EMG data is recorded through each movement.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Trunk stability
Description
The patient is asked to perform a systematic set of reaching movements while seated freely (without a back-rest). Additionally, the patient is asked to perform a set of movements deemed functionally relevant, for example reaching for an object behind them or picking up an object from the ground. Each movement is repeated and EMG data can be acquired.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Respiratory function evaluation
Description
The respiratory function is evaluated using a spirometer. Volume is recorded.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Respiratory function evaluation
Description
The respiratory function is evaluated using a spirometer. Flow is recorded.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Orthostatic head-up tilt test
Description
Patients begin by resting in the supine position during which a baseline recording is performed. Thereafter, patients will be passively moved to upright position using the tilt-table. Between each experimental condition, the patient will be moved back in supine position to return to baseline. Beat-to-beat blood pressure will be monitored.
Time Frame
At baseline and during the rehabilitation phase, an average of 7 months
Title
Autonomic Dysfunction Following Spinal cord injury (ADFSCI)
Description
The ADFSCI questionnaire is a 24-item self-reported questionnaire. The questionnaire consists of demographics, medications, frequency/severity of symptoms during AD and hypotensive events. Higher scores indicate more severe and more frequent symptoms during AD and hypotensive events.
Time Frame
At baseline and monthly during the rehabilitation phase, an average of 7 months
Title
Quality of Life questionnaire WHOQOL-BREF
Description
The WHOQOL-BREF is a questionnaire used to assess the quality of life. Scores are converted to range between 4-20 or 0-100 and are scaled in a positive direction: higher scores denote higher quality of life.
Time Frame
At baseline and monthly during the rehabilitation phase, an average of 7 months
Title
Completion of a Daily Stimulation Log (DSL) by the patient
Description
The patient will be asked to self-report the use of TESS during the at-home phases. This information will be used to evaluate hemodynamic TESS-supported at-home stimulation sessions and characterize the use of the investigational system at home.
Time Frame
From daily at-home supervised used until the end of the study, an average of 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 70 years old Able to undergo the informed consent/assent process Radiologically confirmed spinal cord injury Spinal cord injury between C3 and T6 Classified with AIS A or B Spinal cord injury Stable medical, physical and psychological condition as considered by Investigators Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation Confirmed orthostatic hypotension and autonomic dysreflexia Willing to attend all scheduled appointments Exclusion Criteria: Patients in an emergency situation 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 Other conditions that would make the subject unable to participate in testing in the judgment of the investigators Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the investigators Clinically significant mental illness in the judgment of the investigators Botulinum toxin injections in the previous 6 months Presence of significant pressure ulcers Recurrent urinary tract infection refractory to antibiotics Current pregnancy Current breastfeeding Known or suspected drug or alcohol abuse Unhealed spinal fractures Presence of indwelling baclofen or insulin pump
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne Bloch, MD
Phone
41795562951
Email
jocelyne.bloch@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
John-Paul Miroz
Phone
41795568979
Email
John-Paul.Miroz@chuv.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 Bloch, MD
Phone
0041795562951
Email
jocelyne.bloch@chuv.ch
First Name & Middle Initial & Last Name & Degree
Suzanne Dubsky
Phone
0041795568979
Email
suzanne.dubsky@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
No
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Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury

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