The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations
Visit 1 - Screening Visit 2 - Baseline Assessments Visit 3 - Baseline EMG Mapping of Spinal Cord Segments with transcutaneous spinal cord stimulation Visits 4-9 - Transcutaneous spinal cord stimulation HOME-BASED Therapy (6 weeks) Visit 10 - Post-treatment Autonomic Function Assessments Visit 11 - Post-treatment Cardiac Function Assessments
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
RECRUITINGSystolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS
Changes in SBP measures will be used to establish the BP component of the safety protocol for home-based TSCS with the purpose to mitigate orthostatic hypotension (OH).
Time frame: 6 weeks
Blood pressure (BP) changes in millimeters of mercury (mmHg) in 24-hrs
BP changes will be used to test the safety and feasibility of home-based TSCS (6 weeks) for orthostatic tolerance and bowel function in daily activities. The primary safety and feasibility measures will be continuously measured BP with a wireless BP device (Caretaker Medical LLC, USA, Class II, Medical Device Licence 320275) with and without stimulation, skin condition, any adverse event reports related to the stimulation.
Time frame: 6 weeks
24-hour BP measurement in millimeters of mercury (mmHg)
BP data (i.e., systolic BP) will be monitored and used as a secondary safety measure in relation to better understanding OH in the context of the time course of cardiovascular changes in 24-hours.
Time frame: 6 weeks
Cardiovascular monitoring in mmHg
Beat-by-beat oscillometric cardiovascular monitoring (i.e., mmHg) will be tracked and used as a secondary safety measure in relation to better understanding OH in the context of the time course of cardiovascular function during the mock home-based sessions.
Time frame: 6 weeks
Adverse events (i.e., abnormal electrocardiograph)
Adverse events (i.e., abnormal electrocardiograph) will be tracked and used as a secondary safety measure in relation to better understanding OH in the context of the time course of the frequency and type of adverse events that can occur during mock home-based sessions.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.