Short-term transcutaneous spinal cord stimulation for Autonomic Dysreflexia

N/A

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in project 1 and 3: before and after one hour spinal cord stimulation. in project 2: 24 hours before the first stimulation session and after the last stimulation session (session 21, 4 weeks after the first session).

Awards & highlights

Study Summary

will be recruited. Participants will randomly receive one-month stimulation under each of the two stimulation conditions in a crossover manner: Mid-thoracic and Lumbosacral. For aim 3, 28 individuals with spinal cord injury and no implanted electrode will be recruited. Participants will randomly receive one

Eligible Conditions

Autonomic Dysreflexia
Spinal Cord Injury
Orthostatic Hypotension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in project 1 and 3: before and after one hour spinal cord stimulation. in project 2: 24 hours before the first stimulation session and after the last stimulation session (session 21, 4 weeks after the first session).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in project 1 and 3: before and after one hour spinal cord stimulation. in project 2: 24 hours before the first stimulation session and after the last stimulation session (session 21, 4 weeks after the first session).

This trial's timeline: 3 weeks for screening, Varies for treatment, and in project 1 and 3: before and after one hour spinal cord stimulation. in project 2: 24 hours before the first stimulation session and after the last stimulation session (session 21, 4 weeks after the first session). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebral Blood Flow Changes, the unite of measurement is mililitter/(100 gram tissue minute)

Continues Blood Pressure Changes, the unit of measurement is mmHg

Episodic Blood Pressure Changes, the unit of measurement is mmHg

+1 more

Secondary outcome measures

American Spinal Injury Association Impairment Scale (AIS) Changes

Autonomic Dysreflexia

Neurogenic Bowel

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Short-term transcutaneous spinal cord stimulationExperimental Treatment1 Intervention

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).

Group II: Project 3Experimental Treatment1 Intervention

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.

Group III: Long-term transcutaneous spinal cord stimulationExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out