Transcutaneous Spinal Cord Stimulation Home Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorMichael Berger
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Resident of British Columbia, Canada with active provincial medical services plan
Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23
Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA) of the parkinsonian type.
>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
Disqualifiers
Ventilator dependent.
Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
Intrathecal baclofen pump.
Trial design
Design model
Single group
Treatments tested in this trial
Spinal COrd NEuromodulation ("SCONE") Device
DeviceA non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Transcutaneous Spinal Cord StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic 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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael Berger
Lead sponsor
University of British Columbia
Sponsor institution
Vancouver Coastal Health Research Institute
Collaborator
International Collaboration on Repair Discoveries
Collaborator
SpineX Inc.
Collaborator
Vancouver Coastal Health
Collaborator
University of British Columbia
Collaborator
Rick Hansen Foundation
Collaborator
Source ClinicalTrials.gov