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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I am using or willing to use contraception or abstain from sex during and for 28 days after the trial.
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I have problems with urination, bowel movements, or sexual function.
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I have complete paralysis due to a spinal cord injury above my chest.
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I am between 18 and 60 years old.
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My spinal injury is classified as complete or sensory incomplete.
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I don't have any unhealed injuries or infections that could affect testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 - 6 (once), week 15-18 (once), week 27-30 (once) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more
Other outcome measures
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 more

Trial 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
1,413 Previous Clinical Trials
2,466,931 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,164 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

TESCoN device - Lumbosacral stimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05369520 — N/A
Spinal Cord Injury Research Study Groups: Group 1 - Thoracic stimulation, Group 2- Lumbosacral stimulation
Spinal Cord Injury Clinical Trial 2023: TESCoN device - Lumbosacral stimulation Highlights & Side Effects. Trial Name: NCT05369520 — N/A
TESCoN device - Lumbosacral stimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369520 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current openings for participants in this research endeavor?

"The information posted on clinicaltrials.gov reports that this trial is not currently enlisting participants. The study, which was initially listed on the 1st of January 2023 and last updated on October 18th 2022, has ceased accepting candidates at this time; however, there are 925 other trials in progress right now."

Answered by AI

What are the objectives of this research endeavor?

"The main objective of this trial, which shall be measured between Weeks 15-18, is to detect an instantaneous shift in intravesical pressure at maximal volume via urodynamic investigation. Secondary endpoints include: (1) a change in phonetic/letter fluency as determined by the Verbal Fluency Test once TCSCS has been ceased; (2) an immediate alteration in verbal fluency results during HUTT as judged by the VFT; and (3) a modification of cerebral blood flow per transcranial Doppler assessment from baseline to post 8 weeks of TCSCS treatment."

Answered by AI

May I join the research participants of this clinical experiment?

"To participate in this medical trial, prospective patients must have sustained a spinal cord injury and be aged between 18 to 60 years old. Currently, the study is recruiting up to 30 people."

Answered by AI

Is the age limit for enrollment in this experiment set at 75 or younger?

"This clinical trial is open to patients between the ages of 18 and 60. For those too young or too old, there are 142 trials for under-18s and 741 studies catered towards seniors."

Answered by AI

Who else is applying?

What state do they live in?
Maine
How old are they?
18 - 65
What site did they apply to?
Blusson Spinal Cord Centre
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Blusson Spinal Cord Centre: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Noninvasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
Andrei Krassioukov 2023. "Noninvasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05369520.
~15 spots leftby Sep 2025
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