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Neuromodulation

Noninvasive Stimulation for Spinal Cord Injury

N/A
Waitlist Available
Led By Andrei Krassioukov, MD,PhD,FRCPC
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
Documented impaired LUT function
ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
Must not have
Clinically significant depression with thoughts of suicidal ideation or debilitating PTSD
Concurrent use of any medication or treatment that interferes with study outcomes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline; at 8 weeks after treatment vs. sham; following 16 weeks of stimulation; at 8 weeks after stopping stimulation

Summary

"This trial aims to study the safety and effectiveness of a non-invasive spinal cord stimulation technique in helping people with spinal cord injuries recover functions like bladder control, bowel movements, sexual function, and cardiovascular health

Who is the study for?
This trial is for adults with recent spinal cord injuries (3-6 months ago) who are experiencing issues with bladder, bowel, sexual function, or muscle spasms. It's taking place in Canada and Ukraine. Participants will join a study lasting about 33 weeks to see if non-invasive spine stimulation helps improve these functions.
What is being tested?
The SCONE™ device for transcutaneous spinal cord stimulation (TSCS) is being tested. Participants are split into two groups: one gets real TSCS plus regular rehab for 16 weeks; the other starts with fake stimulation then switches to real TSCS after 8 weeks.
What are the potential side effects?
Since this summary does not provide specific side effects of the SCONE™ device, it can be assumed that potential side effects may include discomfort at the site of stimulation, skin irritation from electrode placement, or temporary worsening of symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have documented issues with bladder function.
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My spinal injury level is between C5 and T10 and is classified as severe or moderate.
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I am between 19 and 65 years old.
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I am not pregnant and agree to use birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing severe depression or PTSD with thoughts of harming myself.
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I am not on any medication that could affect the study results.
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I show symptoms of nerve damage in my muscles.
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I have had surgery on my bladder before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline; at 8 weeks after treatment vs. sham; following 16 weeks of stimulation; at 8 weeks after stopping stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline; at 8 weeks after treatment vs. sham; following 16 weeks of stimulation; at 8 weeks after stopping stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Neurogenic Bladder Symptom Score (NBSS)
Secondary study objectives
Mean change in time needed for bowel movement (TNFBM) by at least 50%
Mean change in voiding efficacy by at least 50%

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 TreatmentExperimental Treatment1 Intervention
TSCS at or between cervical spinal segment 5 (C5) and thoracic spinal segment 10 (T10) at Intervention Phases 1 and 2, 8 weeks each.
Group II: Group 2 ShamPlacebo Group1 Intervention
TSCS at or between C5 and T10 at Intervention Phase 2; 8 weeks.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,461 Previous Clinical Trials
2,485,138 Total Patients Enrolled
United States Department of DefenseFED
904 Previous Clinical Trials
333,169 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
68 Patients Enrolled for Irritable Bowel Syndrome
Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation CenterUNKNOWN
~40 spots leftby Oct 2027
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