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New treatment option for Spinal Cord Injury
Official title Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
ClinicalTrials.gov ID: NCT05369520
What this study is testing
- What it's testing
- 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).
- Time commitment: about 4 weeks
- 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 60
You may be able to join if
- Resident of British Columbia, Canada with active provincial medical services plan.
- Male or female, 19-60 years of age.
- Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
- \>1-year post injury, at least 6 months from any spinal surgery.
- American Spinal Injury Association Impairment Scale (AIS) A, B.
You likely can't join if
- 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...
- History of seizures/epilepsy or recurring headaches.
- Clinically significant, unmanaged, depression (to be screened) or ongoing drug abuse.
See the full eligibility criteria
- Resident of British Columbia, Canada with active provincial medical services plan.
- Male or female, 19-60 years of age.
- Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
- \>1-year post injury, at least 6 months from any spinal surgery.
- 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.
- 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 visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of...
- 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...
- Must provide informed consent.
- 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).
- 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 screened) 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 baseline.
- Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
- Past electrode implantation surgery.
- 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 investigator's judgement, would adversely affect the participant's participation in the study.
- Known allergies or sensitivities to both blue dye and beetroot powder.
- Known or suspected gastrointestinal obstruction.
- Persons with active inflammatory bowel disease or a history of bowel perforation.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, 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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 60 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.