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New treatment option for Spinal Cord Injury
Official title FES Cycling With BFR in the Spinal Cord Injury Population
ClinicalTrials.gov ID: NCT07588503
What this study is testing
- What it's testing
- Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury/disease (SCI/D) population. Many SCI/D patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult (≥ 18 to ≤ 75yrs)
- Male or female
- Chronic Injury (\>1yr)
- Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.
- ≥3 Cardiometabolic risk parameters
You likely can't join if
- A prior or current history of venous thromboembolism
- Pressure injury of the pelvis, mid to upper thigh region, or foot
- Managing a lower limb fracture
- Any history of embolic stroke
- Myocardial infarction
- Current untreated hypertension
See the full eligibility criteria
- Adult (≥ 18 to ≤ 75yrs)
- Male or female
- Chronic Injury (\>1yr)
- Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.
- ≥3 Cardiometabolic risk parameters
- A prior or current history of venous thromboembolism
- Pressure injury of the pelvis, mid to upper thigh region, or foot
- Managing a lower limb fracture
- Any history of embolic stroke
- Myocardial infarction
- Current untreated hypertension
- Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and/or operate the device.
- Current alcohol or street drug use disorder.
- Current use of an anticoagulant medication.
- Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).
- Unresolved deep vein thromboembolism (VTE) in the past six months.
- Severe spasticity preventing the necessary range of motion for cycling.
- Active implantable medical device (e.g., pacemaker, ITB pump).
- Inability to provide informed consent.
- Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).
- Unstable spine or unhealed limbs or pelvic fractures.
- Active heterotopic ossification interfering with the lower extremity range of motion.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, 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.