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

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ClinicalTrials.gov Identifier: NCT05044923
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Aaron Phillips, University of Calgary

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 participants with chronic cervical or high-thoracic spinal cord injury. The ultimate objective of this 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 individuals with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, and quality of life in participants with chronic spinal cord injury will be evaluated.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Targeted Epidural Spinal Stimulation Not Applicable

Detailed Description:

Clinical management of chronic hemodynamic instability is currently limited to long-acting pressor agents and anti-hypertensives. These drugs have significant limitations as they require roughly one hour to become active and exert prolonged influences on the cardiovascular system. This slow timescale contrasts with the hemodynamic instability experienced by people with spinal cord injury, which occurs most commonly over just a few minutes, and tends to cease abruptly. This study will investigate a new therapy for managing hemodynamic instability in individuals with spinal cord injury: Targeted Epidural Spinal Stimulation (TESS).

Here, the investigators propose to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability in participants 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 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 investigators aim to evaluate the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, spasticity, trunk stability, sleep and quality of life in participants with chronic spinal cord injury.

The HEMO Trial will implant 4 participants with chronic (>12 months) spinal cord injury located between C3 and T6 who have confirmed severe orthostatic hypotension and autonomic dysreflexia. Enrolled participants will undergo baseline assessments, after which they will be implanted with the investigational system. Participants 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 conducted for two weeks. Thereafter, and up to 25 weeks post-implant, participants will conduct supported at-home sessions as well as regular laboratory visits during a long-term at-home hemodynamic TESS phase. Finally, participants will 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. Several clinical evaluations are planned to evaluate participants' hemodynamic and neurological status, cardiovascular functional status, respiratory function, trunk stability, and quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-site, single-are, non-blinded, non-randomized, interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Targeted Epidural Spinal Stimulation
Participants will undergo surgery to implant devices that will be used for Targeted Epidural Spinal Stimulation (TESS).
Device: Targeted Epidural Spinal Stimulation
Two lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) will be implanted epidurally over the dorsal aspect of the spinal cord through two laminotomies. Two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic) will be connected to the lead electrodes and implanted in the upper buttocks of the participant.




Primary Outcome Measures :
  1. 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 [ Time Frame: From implant surgery through study completion, an average of 7 months ]
    Investigate the preliminary safety of hemodynamic targeted epidural spinal stimulation (TESS) to modulate pressor responses and manage blood pressure instability in participants with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension.


Secondary Outcome Measures :
  1. Orthostatic head-up tilt test [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Beat-by-beat blood pressure is recorded as participants are passively tilted from a supine position to an upright position using a motorized table.

  2. Daily stimulation log [ Time Frame: From implant surgery through study completion, an average of 7 months ]
    Participants will self-report the use of Targeted Epidural Spinal Stimulation (TESS).

  3. Echocardiogram (Ejection Fraction) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Ultrasound will be used to assess cardiac structure and function. Ejection fraction will be recorded.

  4. Echocardiogram (Strain) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Ultrasound will be used to assess cardiac structure and function. Global longitudinal strain will be recorded.

  5. Vascular ultrasound [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Flow-mediated dilation assessments will be performed using ultrasound to assess vascular structure and function.

  6. Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) Questionnaire [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    The ADFSCI is a 24-item self-report questionnaire. The questionnaire consists of demographics, medications, frequency/severity of symptoms during AD and hypotensive events. Higher scores indicate greater severity and frequency of AD episodes.

  7. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.

  8. Respiratory function evaluation (Volume) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Respiratory function will be assessed using a spirometer while the participant performs a systematic set of breathing tasks. Volume will be recorded.

  9. Respiratory function evaluation (Flow) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    Respiratory function will be assessed using a spirometer while the participant performs a systematic set of breathing tasks. Flow will be recorded.

  10. Quality of life questionnaire (WHOQOL-BREF) [ Time Frame: At baseline and during the testing phase, an average of 9 months ]
    The WHOQOL-BREF is a 26-item self-report questionnaire. The questionnaire covers physical and psychological health, social relationships, and environment. Higher scores indicate higher quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 American Spinal Injury Association Impairment Scale (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:

  • 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 trial in the judgement of the investigators
  • Current clinical diagnosis of mental illness
  • Clinically significant cognitive impairment
  • Current substance or alcohol abuse
  • Botulinum toxin injections in the previous 6 months
  • Presence of significant pressure ulcers
  • Recurrent urinary tract infection refractory to antibiotics
  • Current pregnancy
  • Current breast feeding
  • Unhealed spinal fractures
  • Presence of indwelling baclofen or insulin pump

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044923


Contacts
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Contact: Study Coordinator 4032107438 restorenetwork@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Study Coordinator    4032107438    restorenetwork@ucalgary.ca   
Sponsors and Collaborators
Aaron Phillips
Investigators
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Principal Investigator: Aaron Phillips, PhD University of Calgary
Publications:

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Responsible Party: Aaron Phillips, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT05044923    
Other Study ID Numbers: REB21-0027
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Aaron Phillips, University of Calgary:
orthostatic hypotension
autonomic dysreflexia
epidural stimulation
blood pressure
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System