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Neurostimulation
Spinal Cord Stimulation for Spinal Cord Injury
N/A
Waitlist Available
Led By Andrei Krassioukov, MD, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For sexually active males with female partners of childbearing potential, use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment
Documented impaired lower urinary tract, bowel or sexual function
Must not have
History of gastrointestinal atresia or stenosis
History of seizures/epilepsy or recurring headaches
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
Awards & highlights
Summary
This trial is testing a new way to help people with spinal cord injuries by stimulating the spine with electrical signals.
Who is the study for?
This trial is for adults aged 18-60 in British Columbia with chronic, non-progressive spinal cord injury at or above T6 and complete motor paralysis. Participants must be over a year post-injury, not have severe unrelated health issues, and use contraception if of childbearing potential.
What is being tested?
The study tests the effectiveness of a noninvasive device called TESCoN for thoracic and lumbosacral stimulation to improve autonomic functions impaired by spinal cord injuries. It's a pilot trial to see how well it works to enhance life quality.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort at the stimulation site, skin irritation from electrode placement, or muscle spasms due to electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or willing to use contraception or abstain from sex during and for 28 days after the trial.
Select...
I have problems with urination, bowel movements, or sexual function.
Select...
I have complete paralysis due to a spinal cord injury above my chest.
Select...
I am between 18 and 60 years old.
Select...
My spinal injury is classified as complete or sensory incomplete.
Select...
I don't have any unhealed injuries or infections that could affect testing.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a blockage or narrowing in my digestive tract.
Select...
I have a history of seizures, epilepsy, or recurring headaches.
Select...
I take more than 60mg of baclofen daily.
Select...
I have a history of heart, lung, bladder, or kidney disease not related to spinal cord injury.
Select...
I have had surgery to implant an electrode.
Select...
I have not had severe anemia or significant blood volume loss in the last 6 months.
Select...
I rely on a machine to help me breathe.
Select...
I have signs of nerve damage in my lower spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Baseline assessment of colonic motility using the wireless motility capsule
Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS
Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS
+32 moreSecondary study objectives
Change in CBF measured by TCD during HUTT from baseline to 8 weeks after TCSCS cessation
Change in CBF measured by TCD during HUTT from baseline to after completion of 8 weeks of TCSCS
Change in performance on SCW from baseline to 8 weeks after TCSCS cessation
+6 moreOther study objectives
Frequency of fecal incontinence will be measured using the modified Wexner Fecal Incontinence Score (WIS).
Frequency of urinary incontinence will be measured using The Incontinence-Quality of Life (I-QoL) questionnaire.
Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group 2- Lumbosacral stimulationExperimental Treatment1 Intervention
Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.
Group II: Group 1 - Thoracic stimulationExperimental Treatment1 Intervention
Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels.
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,160 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,448 Total Patients Enrolled
Andrei Krassioukov, MD, PhDPrincipal InvestigatorThe University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
2 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use contraception or abstain from sex during and for 28 days after the trial.I don't have any severe health issues or take medications that would interfere with the study.I can understand and complete English questionnaires or have access to a suitable interpreter.My spinal cord condition is currently stable.I don't have any unhealed injuries or infections that would affect testing.Use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.I have problems with urination, bowel movements, or sexual function.You have a spinal cord injury classified as AIS grade A or B.I have complete paralysis from a spinal injury above my chest.It has been over a year since my injury and more than 6 months since any spinal surgery.My spinal cord condition is currently stable.I have had a blockage or narrowing in my digestive tract.I have a history of seizures, epilepsy, or recurring headaches.I am not pregnant, breastfeeding, or planning to become pregnant.I take more than 60mg of baclofen daily.I have a history of heart, lung, bladder, or kidney disease not related to spinal cord injury.I am on a stable birth control regimen and will continue it during and 28 days after the trial.I have had Botox injections for bladder or sphincter issues within the last 9 months.I have complete paralysis due to a spinal cord injury above my chest.I am not pregnant and will undergo monthly pregnancy tests if I can have children.I am between 18 and 60 years old.My spinal injury is classified as complete or sensory incomplete.I have had surgery to implant an electrode.I have not had severe anemia or significant blood volume loss in the last 6 months.I rely on a machine to help me breathe.I don't have any unhealed injuries or infections that could affect testing.I have signs of nerve damage in my lower spine.You are a resident of British Columbia, Canada with active provincial medical services plan.I am between 18 and 60 years old.It has been over a year since my injury and at least 6 months since any spinal surgery.I have problems with urination, bowel movements, or sexual function.I am not pregnant and will take monthly pregnancy tests if I can have children.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - Thoracic stimulation
- Group 2: Group 2- Lumbosacral stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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