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

  • STATUS
    Recruiting
  • End date
    Jun 7, 2023
  • participants needed
    8
  • sponsor
    Jocelyne Bloch
Updated on 7 June 2022
spasticity
spinal cord
spinal cord disorder
autonomic dysreflexia
spinal cord injury thoracic

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.

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).

Details
Condition Spinal Cord Injuries
Treatment Device implantation
Clinical Study IdentifierNCT04994886
SponsorJocelyne Bloch
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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