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

Status: Terminated
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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

Locations
Other Locations
Switzerland
CHUV
Lausanne
Time Frame
Start Date: 2021-06-08
Completion Date: 2024-12-18
Participants
Target number of participants: 4
Treatments
Experimental: Targeted Epidural Spinal Stimulation
Participants will undergo a surgery for Targeted Epidural Spinal Stimulation (TESS). The neurostimulation system will be used to manage blood pressure instability.~Patients 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 tested for 5 sessions per week for two weeks. Thereafter, and up to 10 months post-implant, patients will have a minimum of 5 TESS supported at-home sessions per week and one laboratory visit per month during a long-term at-home hemodynamic TESS phase. Finally, patients will have to 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.
Sponsors
Leads: Jocelyne Bloch

This content was sourced from clinicaltrials.gov