Comparing TESCoN or SCONE device - Thoracic with TESCoN or SCONE device - Lumbosacral for spinal cord injury
Official title: Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice
- 2 groups
- 2 sites in Vancouver
- Recruiting
Interventions
- Medical device
TESCoN or SCONE device - Thoracic stimulation
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the thoracic spinal cord.
- Medical device
TESCoN or SCONE device - Lumbosacral stimulation
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the lumbosacral spinal cord.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Blusson Spinal Cord Centre
Vancouver, British Columbia
- Recruiting
St Paul's Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for32 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female, 19-60 years of age.
- +Resident of British Columbia, Canada with active provincial medical services plan.
- +Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
- +American Spinal Injury Association Impairment Scale (AIS) A, B.
- +Stable management of spinal cord related clinical issues (i.e., spasticity management).
- +Experience bladder, or bowel, or sexual dysfunction.
- +No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- +Must provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →).
- +For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- +A confirmed negative pregnancy test prior to the baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
- +Use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
- +If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.
- +For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
- +\>1-year post injury, at least 6 months from any spinal surgery.
Exclusion
- −Known allergies or sensitivities to both blue dye and beetroot powder.
- −Ventilator dependent.
- −Signs of lower motor neuron damage (i.e. concomitant conus medullaris/cauda equina injury).
- −Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.
- −History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
- −History of seizures/epilepsy or recurring headaches.
- −Clinically significant, unmanaged, depression (to be screenedScreeningThe checks done before joining, to see whether a study fits.Read more →) or ongoing drug abuse.
- −Intrathecal baclofen pump.
- −Oral baclofen dose greater than 60mg.
- −Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- −Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
- −Member of the investigational team or his/her immediate family.
- −Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgement, would adversely affect the participant's participation in the study.
- −Known or suspected gastrointestinal obstruction.
- −Persons with active inflammatory bowel disease or a history of bowel perforation.
- −Past electrode implantation 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 TESCoN or SCONE device - Thoracic stimulation.
Registry label: A: Group 1 - Thoracic stimulation
Group B receives TESCoN or SCONE device - Lumbosacral stimulation.
Registry label: B: Group 2- Lumbosacral stimulation
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.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
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 60 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 30 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: Week 1-2 (once).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Targeted TCSCS map modulate resting blood pressure (BP) — measured over Week 1-2 (once).
Targeted TCSCS map to activate skeletal muscles and pelvic floor muscles — measured over Week 1-2 (once).
Immediate change in BP during the head up tilt test (HUTT) — measured over Week 3 - 6 (once).
Change in BP during the head up tilt test (HUTT) from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to after completion of 8 weeks of TCSCS — measured over Week 15-18 (once).
The study lists 31 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05369520 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 TESCoN or SCONE device - Thoracic stimulationDevice
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the thoracic spinal cord.
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
About TESCoN or SCONE device - Lumbosacral stimulationDevice
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the lumbosacral spinal cord.
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 60 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 does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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 60 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: Week 1-2 (once).
The study as a whole is currently expected to finish around 2027-10.
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 30 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
This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
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.