Recruiting · registry statusTesting stimulation through the skin at home
Researchers test the safety and feasibility of home spinal stimulation through the skin for blood pressure and bowel problems in selected neurological conditions.
Testing a treatment or activity · Study reference: NCT06838637
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
Open the official registry record ↗Follow this study
Looking for volunteers
- Start (reported actual date)
- 2024-02-15
- Main measurements finished (planned)
- 2026-04-01
- Study finished (planned)
- 2026-04-01
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 19 years to 70 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
INCLUSION CRITERIA
* A participant must meet all of the following criteria in order to be eligible for inclusion:
1. Resident of British Columbia, Canada with active provincial medical services plan
2. 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
3. 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.
4. \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
5. American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. 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).
8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Stable management of spinal cord related clinical issues (i.e., spasticity management).
10. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
10.1. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
10.2. 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.
11. 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.
12. Must provide informed consent.
EXCLUSION CRITERIA
* A participant who meets any of the following criteria will be ineligible to participate:
1. Ventilator dependent.
2. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
3. 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.
4. Intrathecal baclofen pump.
5. Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.
6. 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.
7. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
8. Takes more than 40mg of Baclofen per day.
9. 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.
10. Participant is a member of the investigational team or his/her immediate family.
11. Participant has undergone electrode implantation surgery.
Full study name & original research details
Official study title
The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions
Short title used by the registry
Transcutaneous Spinal Cord Stimulation Home Study
Original description
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
Further 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
Conditions reported: Spinal Cord Injuries; Multiple System Atrophy, Parkinson Variant
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Spinal COrd NEuromodulation ("SCONE") Device
- Phases
- NA
- Sponsor
- Michael Berger
- Start date reported by registry
- 2024-02-15 (actual)
Registry updated: 2025-02-20 · Status last verified by the registry submitter: 2025-02
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Andrea Maharaj, BSc · 604-675-8856 · amaharaj@icord.org
Andrei Krassioukov, MD, FRCPC · 604-675-8816 · krassioukov@icord.org
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
RecruitingAndrea Maharaj, BSc · 604-675-8856 · amaharaj@icord.org
Michael J Berger, MD, FRCPC · 604-675-8852 · Michael.Berger@vch.ca
Facility not reported
Canada
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.