Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury (STIMO HEMO)
Spinal Cord Injuries
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring SCI, Spinal Cord Injury, Epidural Spinal Stimulation
Eligibility Criteria
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
Sites / Locations
- CHUVRecruiting
Arms of the Study
Arm 1
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.