Actively Recruiting
Transcutaneous Spinal Cord Stimulation Home Study
Led by Michael Berger · Updated on 2025-02-20
6
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
M
Michael Berger
Lead Sponsor
V
Vancouver Coastal Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Transcutaneous Spinal Cord Stimulation Home Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female aged 19 to 70 years
- Chronic spinal cord injury at or above T6 with complete motor paralysis or multiple system atrophy of parkinsonian type
- More than 1 year post-injury or diagnosis and at least 6 months from any spinal surgery
- American Spinal Injury Association Impairment Scale A or B for spinal cord injury, or orthostatic hypotension for multiple system atrophy
- Willing and able to comply with all clinic visits and study procedures
- Able to understand and complete study questionnaires in English or with an interpreter
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection interfering with testing
- Stable management of spinal cord related clinical issues
- Women of childbearing potential must not be pregnant, lactating, or intending pregnancy and must have a negative pregnancy test before baseline
- Women of childbearing potential must agree to use effective contraception during the trial and 28 days after
- Sexually active males with female partners of childbearing potential must use effective contraception during the trial and 28 days after
- Must provide informed consent
You will not qualify if you...
- Ventilator dependent
- Clinically significant unmanaged depression or ongoing drug abuse
- Use of medication or treatment deemed unsafe by investigator
- Presence of intrathecal baclofen pump
- Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury or presence of hydronephrosis or obstructive renal stones
- Severe acute medical issues that would affect participation, such as acute urinary tract infections or unstable diabetes
- Any implanted metal in the skull (except dental implants) or pacemakers, stimulators, or medication pumps in the trunk
- Taking more than 40 mg of Baclofen daily
- Severe anemia or hypovolemia as measured by blood tests in the last six months
- Member of the investigational team or immediate family
- Previous electrode implantation surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
A
Andrea Maharaj, BSc
CONTACT
A
Andrei Krassioukov, MD, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here