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

December 20, 2021 updated by: Aaron Phillips
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From implant surgery through study completion, an average of 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and during the testing phase, an average of 9 months
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).
From implant surgery through study completion, an average of 7 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months
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.
At baseline and during the testing phase, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aaron Phillips

Investigators

  • Principal Investigator: Aaron Phillips, PhD, University Of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Targeted Epidural Spinal Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe