What side effects are associated with this type of intervention?

The most common side effects of non-invasive electrical stimulation treatments like Transcutaneous Spinal Cord Stimulation (TCSCS) include mild device-associated adverse events such as a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. These side effects are generally mild, and no serious adverse events have been reported.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of neurogenic bowel using Transcutaneous Spinal Cord Stimulation (TCSCS). However, non-invasive electrical stimulation techniques, such as Transcutaneous Electrical Nerve Stimulation (TENS), have been explored for various types of pain and motor recovery. These methods are based on similar principles of promoting motor and autonomic recovery through electrical stimulation applied over the skin. While TENS is commonly used for pain management, its application for neurogenic bowel specifically remains an area of ongoing research.

What other types of research exist?

Promising novel alternatives to TCSCS for neurogenic bowel patients include: 1) Sacral Nerve Stimulation (SNS), which involves placing a small wire under the skin to send electrical pulses to sacral nerves, and 2) Gastric Electrical Stimulation (GES), which has shown potential in modulating autonomic functions. Both methods are minimally invasive and have demonstrated efficacy in related conditions.

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Neuromodulation Device

Spinal Cord Stimulation for Bladder, Bowel, and Sexual Dysfunction

N/A

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 3-4, week 19, week 25

Awards & highlights

Summary

This trial is testing a non-invasive treatment called TCSCS that uses electrical currents applied to the skin to help people with spinal cord injuries improve their bladder, bowel, and sexual functions. The goal is to offer a simpler and cheaper alternative to surgery. Electrical stimulation for bladder control has been explored as an alternative to traditional methods for treating neurogenic lower urinary tract dysfunction (NLUTD) resulting from spinal cord injury (SCI).

Who is the study for?

This trial is for adults aged 18-65 in British Columbia with chronic traumatic spinal cord injury above T6, complete motor paralysis, and documented bladder or sexual dysfunction. They must not be pregnant or planning pregnancy, agree to use contraception, have stable SCI management, no recent surgeries or infections that could interfere with the study, and sufficient hand function or caregiver support for catheterization.

What is being tested?

The trial tests Transcutaneous Spinal Cord Stimulation (TCSCS), a non-invasive method using skin-applied electrodes to improve bladder, bowel, and sexual function after spinal cord injury. It aims to offer an alternative to invasive implanted stimulators by exploring TCSCS's potential benefits without surgery.

What are the potential side effects?

While specific side effects of TCSCS are not detailed here, similar electrical stimulation treatments can sometimes cause discomfort at the electrode site, muscle twitching during stimulation sessions and may potentially alter blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 3-4, week 19, week 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 3-4, week 19, week 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 3-4, week 19, week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in bladder capacity measured by urodynamics

Change in resting anorectal pressure determined via anorectal manometry

Secondary outcome measures

Blood pressure will be measured continuously during TCSCS

Change in 24-hour blood pressure monitoring

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

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: ModerateExperimental Treatment1 Intervention

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

Group II: IntensiveExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-invasive electrical stimulation treatments, such as Transcutaneous Spinal Cord Stimulation (TCSCS), work by applying electrical currents through electrodes placed on the skin. These currents stimulate the nerves and muscles involved in bowel function, promoting motor and autonomic recovery. This stimulation can enhance peristalsis, improve coordination of bowel movements, and increase the efficiency of the defecation process. For patients with Neurogenic Bowel, these treatments are crucial as they can significantly improve bowel control, reduce constipation and incontinence, and enhance overall quality of life without the need for invasive surgical procedures.

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Who is running the clinical trial?

International Collaboration on Repair DiscoveriesOTHER

7 Previous Clinical Trials

185 Total Patients Enrolled

Providence Health & ServicesOTHER

119 Previous Clinical Trials

822,547 Total Patients Enrolled

International Spinal Research TrustOTHER

5 Previous Clinical Trials

57 Total Patients Enrolled

~12 spots leftby Sep 2025

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