Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury

NCT04604951 | Recruiting DMC

• 2 other identifiers: H20-011632019-1092
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder; Neurogenic Bowel; Spinal Cord Stimulation; Sexual Dysfunction, Physiological

Keywords

Transcutaneous Spinal Cord Stimulation; Noninvasive Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (2)

• Change in bladder capacity measured by urodynamics

  Changes from baseline during TCSCS (%) in bladder capacity will be calculated. Urodynamics 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 and after long-term TCSCS.

  Weeks 4-6, Week 19

• Change in resting anorectal pressure determined via anorectal manometry

  Anorectal manometry will be performed without and with TCSCS to assess the impact of TCSCS on anorectal pressure.

  Weeks 4-6

Secondary Outcomes (13)

• Surface EMG recording with TCSCS

  Weeks 3-4

• Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score

  Week 1, Week 19

• Change in Autonomic Dysfunction following Spinal Cord Injury (ADFSCI) score

  Week 1, Week 19

• Change in Neurogenic Bladder Symptom Score (NBSS)

  Weeks 3-4, Week 19, Week 25

• Change in the Incontinence Quality of Life (I-QoL) score

  Weeks 3-4, Week 19, Week 25

Study Arms (2)

Moderate

EXPERIMENTAL

Group 1: Moderate 2 times per week transcutaneous spinal cord stimulation.

Device: Transcutaneous Spinal Cord Stimulation

Intensive

EXPERIMENTAL

Group 2: Intensive 5 times per week transcutaneous spinal cord stimulation.

Device: Transcutaneous Spinal Cord Stimulation

Interventions

Transcutaneous Spinal Cord Stimulation DEVICE

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.

Also known as: Noninvasive spinal cord stimulation

Intensive; Moderate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A participant who meets any of the following criteria will be ineligible to participate:
• 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:
• Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
• Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin \[total\]; GGT) as judged by the investigator.
• Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
• Ventilator dependent
• Clinically significant depression or ongoing drug abuse
• 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.
• Intrathecal baclofen pump.
• Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
• 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.
• Severe anemia (Hgb\<8 g/dl) or hypovolemia
• Participant is a member of the investigational team or his /her immediate family.
• Participant has undergone electrode implantation surgery.

Sponsors & Collaborators

• University of British Columbia: lead
• International Spinal Research Trust: collaborator
• International Collaboration on Repair Discoveries: collaborator
• Providence Health & Services: collaborator

Study Sites (2)

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

ENROLLING BY INVITATION

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Neurogenic Bowel; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases

Study Officials

• Andrei Krassioukov, MD,PhD,FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura McCracken, MSc

CONTACT

6046758816; mccracken@icord.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 27, 2020
• Study Start: May 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)