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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
114 Previous Clinical Trials
21,337 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the central aim of this medical study?

"The primary objective of this assessment, to be completed within three weeks of enrollment, is the evaluation of anal sphincter function. Subsidiary objectives include a voluntary contraction test monitored by an SCI-specialized clinician (which will form part of the ISNCSCI examination), Medical history and Demographics data collection regarding body system categories, gender identity, birth date, ethnicity etc.."

Answered by AI

To what extent is this medical study being participated in?

"Affirmative, the information available from clinicaltrials.gov shows that this investigation is presently looking for individuals to join in. The research project was first made public on December 1st 2022 with an update being posted as recently as November 15th of the same year. Fifty-two participants are required between one location."

Answered by AI

Is this research endeavor presently enlisting participants?

"Affirmative. The information available at clinicaltrials.gov suggests that this research endeavour is presently enrolling participants. This examination was first posted on December 1st 2022 and recently revised on November 15th 2022, with 52 individuals being sought from one site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
MetroHealth Medical System Old Brooklyn Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Stop worries about inconstancy.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. MetroHealth Medical System Old Brooklyn Campus: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Robert Hoey 2023. "Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626816.
All > Sci
~20 spots leftby Dec 2024
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