Testing Spinal COrd NEuromodulation™ (SCONE™) against a placebo for spinal cord injuries
Official title: Noninvasive Spinal Cord Stimulation for Early SCI
Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans
- 2 groups
- One site, in Vancouver
- Recruiting
Interventions
- Medical device
Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS)
The SCONE™ class II investigational device is a non-invasive central nervous system (CNS) stimulator (electrical continence device) designed to provide transcutaneous spinal cord stimulation for the improvement of symptoms of bladder dysfunction associated with centrally-mediated NLUTD.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Blusson Spinal Cord Centre
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Be a resident of either British Columbia (for Vancouver SiteTrial siteA hospital or clinic where a study is actually run.Read more →) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age between 19 and 65 years at the time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI
- +A participant must meet all of the following criteria in order to be eligible to participate:
- +ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
- +Documented impaired LUT function
- +Must provide informed consent.
- +Agrees to comply with all planned visits and assessments, adhere with established bowel and LUT routines and refrain from initiation of new medications for bowel and LUT management without notifying the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → of this study.
- +Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- +i. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →.
- +ii. 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.
Exclusion
- −A participant who meets any of the following criteria will be ineligible to participate:
- −Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- −Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
- −History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →.
- −Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
- −Presence of cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study
- −Presence of severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
- −Contraindications for TSCS, such as:
- −Implanted Cardiac pacemaker 8.2 Implanted metal in the trunk or spinal cord 8.3 Intrathecal delivery system (e.g., baclofen pump) 8.4 Implanted central or peripheral neuromodulator
- −Medical condition that may put the participant at risk as determined by the investigator.
- −Participation in or plans to participate in another research study that may interfere with the study endpointsEndpointThe specific thing a study measures to answer its question.Read more →.
- −History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS).
Registry label: A: Group 1 Treatment
Group B, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS).
Registry label: B: Group 2 Sham
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 19 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →; At 8 weeks after treatment vs. shamSham procedureA procedure made to feel like the real one, without the active step.Read more →; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Neurogenic Bladder Symptom Score (NBSS) — measured over At baselineBaselineYour starting measurements, taken before treatment begins.Read more →; At 8 weeks after treatment vs. shamSham procedureA procedure made to feel like the real one, without the active step.Read more →; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06587841 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS)Device
The SCONE™ class II investigational device is a non-invasive central nervous system (CNS) stimulator (electrical continence device) designed to provide transcutaneous spinal cord stimulation for the improvement of symptoms of bladder dysfunction associated with centrally-mediated NLUTD.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 19 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 19 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →; At 8 weeks after treatment vs. shamSham procedureA procedure made to feel like the real one, without the active step.Read more →; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation.
The study as a whole is currently expected to finish around 2027-10-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute and chronic SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.