Transcutaneous Spinal Cord Stimulation Home Study
The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions
1 other identifier
interventional
6
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2024
CompletedFirst Submitted
Initial submission to the registry
February 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 20, 2025
February 1, 2025
2.1 years
February 17, 2025
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
6 weeks
Secondary Outcomes (3)
24-hour BP measurement in millimeters of mercury (mmHg)
6 weeks
Cardiovascular monitoring in mmHg
6 weeks
Adverse events (i.e., abnormal electrocardiograph)
6 weeks
Study Arms (1)
Transcutaneous Spinal Cord Stimulation
EXPERIMENTALTranscutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA).
Interventions
A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.
Eligibility Criteria
You may qualify if:
- 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.
- American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
- Willing and able to comply with all clinic visits and study-related procedures.
- Able 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.
- Stable management of spinal cord related clinical issues (i.e., spasticity management).
- Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
- Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
- Must provide informed consent.
You may not qualify if:
- A participant who meets any of the following criteria will be ineligible to participate:
- 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.
- Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.
- Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
- Takes more than 40mg of Baclofen per day.
- Severe anemia (Hgb\<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
- Participant is a member of the investigational team or his/her immediate family.
- Participant has undergone electrode implantation surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Bergerlead
- Vancouver Coastal Health Research Institutecollaborator
- International Collaboration on Repair Discoveriescollaborator
- SpineX Inc.collaborator
- Vancouver Coastal Healthcollaborator
- University of British Columbiacollaborator
- Rick Hansen Foundationcollaborator
Study Sites (1)
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, V5Z 1M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Berger, MD, FRCPC
The University of British Columbia
- STUDY DIRECTOR
Andrei Krassioukov, MD, FRCPC
The University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
February 17, 2025
First Posted
February 20, 2025
Study Start
February 15, 2024
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
February 20, 2025
Record last verified: 2025-02