ClinicalTrials.gov record NCT06838637
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This single-group interventional study tests a portable non-invasive spinal cord stimulator (SCONE) as a home-based therapy for orthostatic hypotension and bowel dysfunction. Participants have spinal cord injury or the parkinsonian form of multiple system atrophy and follow an in-center setup and mapping period, a 2-week in-clinic treatment phase, then six weeks of home treatment with twice-daily 1-hour sessions, with pre- and post-treatment assessments.
What it is studying. The study is testing the safety and feasibility of delivering transcutaneous spinal cord stimulation at home using the SCONE device, and whether home use can be monitored (including blood pressure and adverse events) while assessing effects on orthostatic hypotension and bowel dysfunction.
What the researchers hope to learn. To establish a safe protocol for home-based transcutaneous spinal cord stimulation; to test safety and feasibility of home use; to collect blood-pressure and adverse-event data and assess effects on orthostatic hypotension and bowel dysfunction.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Spinal COrd NEuromodulation ("SCONE") Device
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- A participant must meet all of the following criteria in order to be eligible for inclusion:
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent, participants attend baseline visits including EMG mapping to plan electrode placement. They complete a 2‑week in‑center treatment period (three visits per week), followed by a 6‑week home‑based therapy involving about 1‑hour sessions twice daily using the SCONE transcutaneous spinal cord stimulation device. Before, during and after the 6‑week period they will have autonomic and cardiac assessments, continuous 24‑hour blood‑pressure monitoring with a wireless device, skin checks, and reporting of any adverse events. Total participation is approximately 10 weeks excluding screening.
How the study is structured. Interventional, single-group, non-masked (open) device study. Participants attend clinic visits for screening, baseline testing, and electrode mapping; receive 2 weeks of in-clinic stimulation (three visits per week); then complete a 6-week home-based therapy of two 1-hour sessions per day. Continuous blood-pressure monitoring and post-treatment autonomic and cardiac assessments are included.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Canada. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Feb 15, 2024
- Primary completion
- Apr 1, 2026 (estimated)
- Study completion
- Apr 1, 2026 (estimated)
- Target enrollment
- 6 participants (estimated)
- Last updated on registry
- Feb 20, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Michael Berger
- Collaborators
- Vancouver Coastal Health Research Institute
- International Collaboration on Repair Discoveries
- SpineX Inc.
- Vancouver Coastal Health
- University of British Columbia
- Rick Hansen Foundation
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Andrea Maharaj, BSc 📞 604-675-8856 ✉ amaharaj@icord.org
- Andrei Krassioukov, MD, FRCPC 📞 604-675-8816 ✉ krassioukov@icord.org
Participating sites (1)
- ICORD, Blusson Spinal Cord CentreRecruiting
Vancouver, British Columbia, V5Z 1M9 · Canada
- Andrea Maharaj, BSc · 604-675-8856 · amaharaj@icord.org
- Michael J Berger, MD, FRCPC · 604-675-8852 · Michael.Berger@vch.ca
Terms used on this page · explanations by MedicalUpdates.ai
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- Women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Intrathecal
- Given by injection into the fluid around the spinal cord, usually through a lumbar puncture.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- INCLUSION CRITERIA
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- EXCLUSION CRITERIA
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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