NCT04994886

Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Jocelyne Bloch · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
PROCEDURE	Device implantation	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.

Timeline

• Start date: 2021-06-08
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2021-08-06
• Last updated: 2025-04-29

Locations

1 site across 1 country: Switzerland