Spinal Cord InjuriesNCT06838637
Transcutaneous Spinal Cord Stimulation Home Study
A study testing Spinal COrd NEuromodulation ("SCONE") Device in people with Spinal Cord Injuries and Multiple System Atrophy, Parkinson Variant, run by Michael Berger at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Multiple System Atrophy, Parkinson Variant
- What is being tested?
- Spinal COrd NEuromodulation ("SCONE") Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, V5Z 1M9
Andrea Maharaj, BSc, 604-675-8856, amaharaj@icord.org
Michael J Berger, MD, FRCPC, 604-675-8852, Michael.Berger@vch.ca
About this study
Official title: The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions
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
Read more
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
Read the detailed description
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
- Being tested
- Spinal COrd NEuromodulation ("SCONE") Device
- Keywords
- Transcutaneous Spinal Cord Stimulation, SCONE, Orthostatic Hypotension, Bowel Dysfunction, Autonomic Dysfunction
- Medical subject headings
- Spinal Cord Injuries, Multiple System Atrophy, Hypotension, Orthostatic, Intestinal Diseases, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal COrd NEuromodulation ("SCONE") DeviceDevice
A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | Transcutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA). Receives: Device: Spinal COrd NEuromodulation ("SCONE") Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Feb 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Berger
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, International Collaboration on Repair Discoveries, SpineX Inc., Vancouver Coastal Health, University of British Columbia, Rick Hansen Foundation
- Responsible party
- Sponsor-investigator, Michael Berger, University of British Columbia
- Investigators
- Michael J Berger, MD, FRCPC, Principal investigator, The University of British ColumbiaAndrei Krassioukov, MD, FRCPC, Study director, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838637
- Sponsor's protocol ID
- H23-00192
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions
- ClinicalTrials.gov ID
- NCT06838637
- Acronym / sponsor ID
- H23-00192
- Keywords
- Transcutaneous Spinal Cord Stimulation, SCONE, Orthostatic Hypotension, Bowel Dysfunction, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Michael BergerUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, International Collaboration on Repair Discoveries, SpineX Inc., Vancouver Coastal Health, University of British Columbia, Rick Hansen Foundation
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | Device: Spinal COrd NEuromodulation ("SCONE") DeviceTranscutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A participant must meet all of the following criteria in order to be eligible for inclusion:
- 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.
Key exclusion criteria (12 listed)
- A participant who meets any of the following criteria will be ineligible to participate:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal COrd NEuromodulation ("SCONE") DeviceA non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source. | Device | Transcutaneous Spinal Cord Stimulation |
Primary outcome
Systolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS
Time frame: 6 weeks
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).
Blood pressure (BP) changes in millimeters of mercury (mmHg) in 24-hrs
Time frame: 6 weeks
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.
3 secondary outcomes
24-hour BP measurement in millimeters of mercury (mmHg)
Time frame: 6 weeks
Cardiovascular monitoring in mmHg
Time frame: 6 weeks
Adverse events (i.e., abnormal electrocardiograph)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Berger, MD, FRCPC principal investigator
The University of British Columbia
Andrei Krassioukov, MD, FRCPC study director
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal COrd NEuromodulation ("SCONE") Device in people with Spinal Cord Injuries and Multiple System Atrophy, Parkinson Variant, run by Michael Berger at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Maharaj, BSc (604-675-8856, amaharaj@icord.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.