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Neuromodulation: Bladder Bowel and Sexual Function in SCI

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ClinicalTrials.gov Identifier: NCT04604951
Recruitment Status : Not yet recruiting
First Posted : October 27, 2020
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
International Spinal Research Trust
International Collaboration on Repair Discoveries
St. Paul's Hospital
Information provided by (Responsible Party):
Andrei Krassioukov, University of British Columbia

Brief Summary:

Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure.

In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neurogenic Bladder Neurogenic Bowel Spinal Cord Stimulation Sexual Dysfunction, Physiological Device: Transcutaneous Spinal Cord Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate
Group 1: Moderate 2 times per week transcutaneous spinal cord stimulation.
Device: Transcutaneous Spinal Cord Stimulation
This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
Other Name: Noninvasive spinal cord stimulation

Experimental: Intensive
Group 2: Intensive 5 times per week transcutaneous spinal cord stimulation.
Device: Transcutaneous Spinal Cord Stimulation
This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
Other Name: Noninvasive spinal cord stimulation




Primary Outcome Measures :
  1. Blood pressure will be measured continuously during transcutaneous spinal cord stimulation (TCSCS). Number of potential adverse cardiovascular events (ACVEs, i.e. autonomic dysreflexia) will be counted. [ Time Frame: Weeks 3-4, Weeks 712 ]
    Continuous blood pressure monitoring will be utilized as a safety measure to detect potential adverse cardiovascular events (ACVEs, i.e. autonomic dysreflexia).

  2. The investigators will measure surface electromyography (EMG) during TCSCS. [ Time Frame: Weeks 3-4 ]
    EMG measurements will allow the investigators to identify the motor threshold for skeletal muscles known to be involved in lower urinary tract and bowel control by delivering TCSCS at various spinal cord segments: T10/T11; T11/T12; T12/L1; L1/L2 (conus medullaris), thereby generating individualized spatiotemporal activation maps.

  3. The investigators will measure the following UDS parameters: volume and intravesical pressure at first sensation, volume and pressure at the leakage point, maximal intravesical volume and intravesical pressure at the maximal volume. [ Time Frame: Weeks 4-6, week 13 ]
    Changes from baseline during TCSCS (%) in the above measures of bladder capacity/compliance will be calculated. UDS will be performed with and without TCSCS during 3 separate sessions to assess the changes from baseline in the parameters listed above. These measures will be compared to assess reproducibility of changes within urodynamic parameters during TCSCS.

  4. Mean maximum resting anorectal pressure will be measured using Anorectal Manometry both without and with TCSCS. [ Time Frame: Weeks 4-6 ]
    Anorectal Manometry will be performed without and with TCSCS to assess the impact of TCSCS on anorectal pressure.

  5. Frequency of urinary incontinence will be measured using The Incontinence-Quality of Life questionnaire. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    Assessment of urinary incontinence will be performed to assess the impact of long term TCSCS on this measure. The scale is a 100 point scale where 0 is most severe incontinence.

  6. Neurogenic Bladder symptoms will be measured using the Neurogenic Bladder Symptom score. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    Assessment of neurogenic bladder symptoms will be performed to assess the impact of long term TCSCS on this measure. The score measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23), with higher scores representing worse symptoms.

  7. Frequency of fecal incontinence will be measured using the modified Wexner fecal incontinence score. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    Assessment of fecal incontinence will be performed to assess the impact of long term TCSCS on this measure. Scores can range from 0-20, with a higher score representing greater incontinence.

  8. Neurogenic bowel symptoms will be measured using the Neurogenic Bowel dysfunction score. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    Assessment neurogenic bowel symptoms will be performed to assess the impact of long term TCSCS on this measure. Scores can range from 0-47, with a higher score representing more severe dysfunction.

  9. Participant's sexual function and satisfaction with their overall sexual life will be measured using The International Index of Erectile Function. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS. Scores can range from 5-25, with higher scores representing greater function.

  10. Participant's sexual function and satisfaction with their overall sexual life will be measured using the Female Sexual Function Index. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS. Scores can range from 2-36, with higher scores representing greater function.

  11. Participant's sexual function and satisfaction with their overall sexual life will be measured using a Semi- structured qualitative interview. [ Time Frame: Weeks 3-4, week 13 week 19, week 25 ]
    This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

A participant must meet all of the following criteria in order to be eligible for inclusion:

  1. Resident of British Columbia, Canada with active provincial medical services plan
  2. Male or female, 18-65 years of age
  3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
  4. >1-year post injury, at least 6 months from any spinal surgery.
  5. Documented presence of bladder dysfunction (NDO during UDS)
  6. Documented presence of bowel or sexual dysfunction.
  7. American Spinal Injury Association Impairment Scale (AIS) A, B.
  8. Greater than or equal to antigravity strength in deltoids and biceps bilaterally
  9. Hand function sufficient to perform Clean Intermittent Catheterization (CIC) or a committed caregiver to provide CIC for management of urinary bladder drainage.
  10. Participants must have documented three days of bladder and bowel history prior to their baseline visit.
  11. 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).
  12. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
  13. Stable management of spinal cord related clinical issues (i.e., spasticity management).
  14. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
  15. Women of childbearing potential must have 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 events.

    Women of childbearing potential must agree to use adequate contraception*~2~* during the period of the trial and for at least 28 days after completion of treatment.

  16. Effective contraception includes abstinence. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
  17. Must provide informed consent.

Exclusion Criteria:

A participant who meets any of the following criteria will be ineligible to participate:

  1. Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications [tricyclics]; or unstable diabetes. The following conditions apply:

    1. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
    2. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin [total]; GGT) as judged by the investigator.
  2. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
  3. Ventilator dependent
  4. Clinically significant depression or ongoing drug abuse
  5. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
  6. Intrathecal baclofen pump.
  7. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
  8. Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive TCSCS.
  9. Severe anemia (Hgb<8 g/dl) or hypovolemia
  10. Participant is a member of the investigational team or his /her immediate family.
  11. Participant has undergone electrode implantation surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604951


Contacts
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Contact: Laura McCracken, MSc 6046758816 mccracken@icord.org

Locations
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Canada, British Columbia
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Laura McCracken, MSc    6046758816    mccracken@icord.org   
Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC         
Sponsors and Collaborators
University of British Columbia
International Spinal Research Trust
International Collaboration on Repair Discoveries
St. Paul's Hospital
Investigators
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Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC University of British Columbia
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Responsible Party: Andrei Krassioukov, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04604951    
Other Study ID Numbers: H20-01163
2019-1092 ( Other Grant/Funding Number: International Spinal Research Trust )
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Krassioukov, University of British Columbia:
Transcutaneous Spinal Cord Stimulation
Noninvasive Spinal Cord Stimulation
Additional relevant MeSH terms:
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Neurogenic Bowel
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Sexual Dysfunction, Physiological
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases