Spinal Cord Stimulation and Autonomic Response in People With SCI.
Spinal Cord Injuries, Autonomic Dysreflexia, Orthostatic Hypotension, Dysautonomic
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Transcutaneous Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, Orthostatic Hypotension, Autonomic Dysreflexia, Spinal Cord Stimulation
Eligibility Criteria
Inclusion Criteria:
- Age limit for Project 1 and Project 2 is 18-65 years, and age limit for Project 3 is 22-65 years (Based on FDA approval, participants below 22 are not allowed undergo to implantation surgery).
- The volunteer should have >1-year injury, at least 6 months from any spinal surgery
- Underwent electrode implantation surgery before
- Documented presence of cardiovascular dysfunction including the presence of persistent resting blood pressure and/or symptoms of AD/OH.
- Greater than or equal to antigravity strength in deltoids and biceps bilaterally.
- Participants must have documented 3 days of bladder and bowel history prior to their baseline visit.
- Willing to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
- Stable management of spinal cord-related clinical issue (spasticity management).
- Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating.
- Sexually active males with female partners of childbearing potential must agree to effective contraception during th eperiod of the tril nad for at least 28 days after completion of treatment.
- Must provide informed consent.
Exclusion Criteria:
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study.
- Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit).
- Ventilator dependent
- Clinically significant depression or ongoing drug abuse
- Use of any medication or treatment that in the opinion of the investigator indicates that it is not the best interest of participant to participate in this study
- Indwelling baclofen pump
- Any implanted metal in the trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive NTSCS.
- Severe anemia (Hgb<8 g/dl) or hypovolemia.
- Participant is a member of the investigational team or his /her immediate family.
Sites / Locations
- University of Calgary
- University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Short-term transcutaneous spinal cord stimulation
Long-term transcutaneous spinal cord stimulation
Project 3
In Project 1, we will measure the immediate effects of one-hour mid-thoracic and/or lumbosacral transcutaneous stimulation on autonomic function. In mid-thoracic stimulation, the self-adhesive cathode electrode with a diameter of 30 mm will be placed on the skin between the TVII and TVIII spinous processes (approximately corresponding to the T8 spinal segment) at the midline over the vertebral column. For lumbosacral stimulation, the cathode will be placed on the skin between the LI and LII spinous processes (approximately corresponding to the L2/3 to S4/5) at the midline over the vertebral column. Two self-adhesive anode electrodes with a size of 5 × 9 cm will be symmetrically located on the skin over the iliac crests. Before and immediately after the stimulation, the outcomes will be measured in 2 positions, supine and ~ 70° upright (adjusted by tilt-up table).
In Project 2, we will measure the effects of one-month stimulation (five one-hour stimulation sessions per week) of mid-thoracic and lumbosacral transcutaneous spinal cord stimulation on autonomic function. The electrode placement and duration of stimulation will be identical to Project 1. The outcomes at each time point will be measured in two positions, supine and ~ 70° upright (adjusted by tilt-up table). The cardiovascular outcomes will be measured before, after the last stimulation session. Bladder and bowel function will be assessed weekly.
For Project 3, only individuals who have previously been implanted with an epidural stimulator will be invited to participate. They will have only one stimulation session. We will not offer participants to undergo implantation surgery.