TESCoN device - Thoracic stimulation for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St Paul's Hospital, Vancouver, Canada
Spinal Cord Injuries+4 More
TESCoN device - Thoracic stimulation - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new way to help people with spinal cord injuries by stimulating the spine with electrical signals. The TESCoN device is a thoracic stimulator that is used to treat Spinal Cord Injuries. This device has previously been approved by the FDA for a different condition. However, in this clinical trial, no patients will receive a placebo.

Eligible Conditions

  • Spinal Cord Injuries
  • Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

35 Primary · 9 Secondary · Reporting Duration: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

Week 1-2 (once)
Targeted TCSCS map modulate resting blood pressure (BP)
Targeted TCSCS map to activate to activate skeletal muscles and pelvic floor muscles
Week 15-18 (once)
Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS
Change in BP during penile or clitoral vibrostimulation from baseline to after completion of 8 weeks of TCSCS
Change in BP during the head up tilt test (HUTT) from baseline to after completion of 8 weeks of TCSCS
Change in CBF measured by TCD during HUTT from baseline to after completion of 8 weeks of TCSCS
Change in colonic motility using the wireless motility capsule from baseline to after completion of 8 weeks of TCSCS
Change in high pressure anal canal zone measured by ARM from baseline to after completion of 8 weeks of TCSCS
Change in intravesical pressure at first sensation measured by UDI from baseline to after completion of 8 weeks of TCSCS
Change in intravesical pressure at leakage point measured by UDI from baseline to after completion of 8 weeks of TCSCS
Change in intravesical pressure at maximal volume measured by UDI from baseline to after completion of 8 weeks of TCSCS
Change in performance on SCW from baseline to after completion of 8 weeks of TCSCS
Change in performance on the VFT from baseline to after completion of 8 weeks of TCSCS
Change in rectal pressure measured by ARM from baseline to after completion of 8 weeks of TCSCS
Change in rectal sensation measured by ARM from baseline to after completion of 8 weeks of TCSCS
Change in recto-anal inhibitory reflex measured by ARM from baseline to after completion of 8 weeks of TCSCS
Week 27-30 (once)
Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS
Change in BP during penile or clitoral vibrostimulation from baseline to 8 weeks after cessation of TCSCS
Change in BP during the head up tilt test (HUTT) from baseline to 8 weeks after cessation of TCSCS
Change in CBF measured by TCD during HUTT from baseline to 8 weeks after TCSCS cessation
Change in colonic motility using the wireless motility capsule from baseline to 8 weeks after TCSCS cessation.
Change in high pressure anal canal zone measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
Change in intravesical pressure at first sensation measured by UDI from baseline to 8 weeks after cessation of TCSCS
Change in intravesical pressure at leakage point measured by UDI from baseline to 8 weeks after cessation of TCSCS
Change in intravesical pressure at maximal volume measured by UDI from baseline to 8 weeks after cessation of TCSCS
Change in performance on SCW from baseline to 8 weeks after TCSCS cessation
Change in performance on the VFT from baseline to 8 weeks after TCSCS cessation
Change in rectal pressure measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
Change in rectal sensation measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
Change in recto-anal inhibitory reflex measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
Week 3
Baseline assessment of colonic motility using the wireless motility capsule
Immediate change in BP during digital anorectal stimulation (DARS)
Immediate change in BP during penile or clitoral vibrostimulation
Immediate change in BP during the head up tilt test (HUTT)
Immediate change in cerebral blood flow (CBF) measured by trans-cranial doppler (TCD) during HUTT
Immediate change in high pressure anal canal zone measured by ARM
Immediate change in intravesical pressure at first sensation measured by urodynamic investigation (UDI)
Immediate change in intravesical pressure at leakage point measured by UDI
Immediate change in intravesical pressure at maximal volume measured by UDI
Immediate change in performance on the Stroop Color and Word (SCW) test during HUTT
Immediate change in performance on the verbal fluency test (VFT) during HUTT
Immediate change in rectal pressure measured by anorectal manometry (ARM)
Immediate change in rectal sensation measured by ARM
Immediate change in recto-anal inhibitory reflex measured by ARM
Week 27
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).
Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
Participant's quality of life will be measured using the Short Form Health Survey (SF-36)
Participant's sensations associated with orgasm will be measured using the Orgasm Rating Scale (ORS).
Participant's sexual function and satisfaction with their overall sexual life will be measured using a semi-structured qualitative interview.
Participant's sexual function and satisfaction with their overall sexual life will be measured using the Female Sexual Function Index (FSFI).
Participant's sexual function and satisfaction with their overall sexual life will be measured using the International Index of Erectile Function (IIEF-15).
Participant's sexually related personal distress will be measured using the Female Sexual Distress Scale (FSDS).
Time Needed for Bowel Movement (TNFBM) will be measured by self-report.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Group 1 - Thoracic stimulation
1 of 2
Group 2- Lumbosacral stimulation
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: TESCoN device - Thoracic stimulation · No Placebo Group · N/A

Group 1 - Thoracic stimulation
Device
Experimental Group · 1 Intervention: TESCoN device - Thoracic stimulation · Intervention Types: Device
Group 2- Lumbosacral stimulation
Device
Experimental Group · 1 Intervention: TESCoN device - Lumbosacral stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 3 - 6 (once), week 15-18 (once), week 27-30 (once)
Closest Location: St Paul's Hospital · Vancouver, Canada
Photo of Vancouver 1Photo of Vancouver 2Photo of Vancouver 3
2012First Recorded Clinical Trial
2 TrialsResearching Spinal Cord Injuries
32 CompletedClinical Trials

Who is running the clinical trial?

United States Department of DefenseFED
761 Previous Clinical Trials
202,222 Total Patients Enrolled
36 Trials studying Spinal Cord Injuries
2,842 Patients Enrolled for Spinal Cord Injuries
University of British ColumbiaLead Sponsor
1,296 Previous Clinical Trials
1,271,277 Total Patients Enrolled
39 Trials studying Spinal Cord Injuries
1,105 Patients Enrolled for Spinal Cord Injuries
Andrei Krassioukov, MD, PhDPrincipal InvestigatorThe University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
2 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Spinal Cord Injuries
5 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a resident of British Columbia, Canada with active provincial medical services plan.
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.
You have a complete spinal cord injury at or above the T6 spinal segment.
You have had a spinal surgery within the past year.
You have stable spasticity management.
Urine pregnancy tests are performed at the baseline visit and at the 12-month follow-up visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.