BridgeMD
New treatment option for Spinal Cord Injuries
Official title Noninvasive Spinal Cord Stimulation for Early SCI
ClinicalTrials.gov ID: NCT06587841
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65
You may be able to join if
- A participant must meet all of the following criteria in order to be eligible to participate:
- Be a resident of either British Columbia (for Vancouver Site) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age...
- Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI
- ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
- Documented impaired LUT function
You likely can't join if
- 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...
- History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- 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 visit.
- Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
See the full eligibility criteria
- A participant must meet all of the following criteria in order to be eligible to participate:
- Be a resident of either British Columbia (for Vancouver Site) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age between 19 and 65 years at the time of consent
- Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI
- ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
- Documented impaired LUT function
- 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...
- 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.
- 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...
- 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 investigator.
- History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- 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 visit.
- 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: 8.1. 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...
- 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 endpoints.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.