Recruiting

Epidural Stimulation

Sponsor:

Aaron Phillips

Code:

NCT05044923

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Targeted Epidural Spinal Stimulation

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05044923

Start date

Dec, 2021

Status verified date

Dec, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Targeted Epidural Spinal Stimulation

Participants will undergo surgery to implant devices that will be used for Targeted Epidural Spinal Stimulation (TESS).

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Study Coordinator

4032107438restorenetwork@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Study Coordinator

4032107438restorenetwork@ucalgary.ca

More Information

Sponsor

Aaron Phillips

Last update posted

Dec 21, 2021

Last verified

Dec, 2021

Keywords

  • orthostatic hypotension
  • autonomic dysreflexia
  • epidural stimulation
  • blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aaron Phillips on 2021-12-21.