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Behavioural Intervention

Genital Nerve Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Kim Anderson, PhD

Research Sponsored by MetroHealth Medical Center

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 during enrollment, up to one week

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effect of non-invasive stimulation on bowel issues in people with spinal cord injury. It aims to reduce fecal incontinence, a common complication of SCI. Data from anorectal manometry will be collected to measure the effect of stimulation.

Who is the study for?

This trial is for adults over 18 with traumatic spinal cord injury (SCI) at least 6 months post-injury, having specific reflexes intact. It's not for those in other electrical stimulation studies, pregnant women, or individuals with certain implants or medical complications that could affect the study.

What is being tested?

The study tests genital nerve stimulation (GNS) using non-invasive electrodes to improve bowel control in SCI patients. It measures anorectal function before and after GNS to determine its effectiveness against fecal incontinence.

What are the potential side effects?

While the description doesn't specify side effects, GNS may cause discomfort or skin irritation where electrodes are placed. There might also be unknown risks since it's a new application of this technology.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during enrollment, up to one week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during enrollment, up to one week

This trial's timeline: 3 weeks for screening, Varies for treatment, and during enrollment, up to one week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ARM outcome - Anal sphincter function

ARM outcome - Presence of hyper reflexive rectal contractions

ARM outcome - Rectal sensation

+2 more

Secondary study objectives

Clinical exam - Anal sphincter tone

Clinical exam - Evaluation of sacral reflexes

Clinical exam - Sensation

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: All interventions, effective stim applied firstExperimental Treatment7 Interventions

These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.

Group II: All interventions, Sham applied firstExperimental Treatment7 Interventions

These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Genital Nerve Stimulation

2019

N/A

~20

Clinical exam

2010

N/A

~350