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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ARM outcome - Anal sphincter function
ARM outcome - Presence of hyper reflexive rectal contractions
ARM outcome - Rectal sensation
+2 more
Secondary outcome measures
Clinical exam - Anal sphincter tone
Clinical exam - Evaluation of sacral reflexes
Clinical exam - Sensation
+8 more

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

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
115 Previous Clinical Trials
21,587 Total Patients Enrolled
VA of Northeast Ohio Health SystemUNKNOWN
Kim Anderson, PhDPrincipal InvestigatorMetroHealth Medical Center

Media Library

Genital Nerve Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05626816 — N/A
Bowel Incontinence Research Study Groups: All interventions, Sham applied first, All interventions, effective stim applied first
Bowel Incontinence Clinical Trial 2023: Genital Nerve Stimulation Highlights & Side Effects. Trial Name: NCT05626816 — N/A
Genital Nerve Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626816 — N/A
~15 spots leftby Dec 2024
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