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TENS for Gastrointestinal Disorders

N/A

Recruiting

Led By Gisela Chelimsky, MD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline and 4 weeks.

Awards & highlights

Study Summary

This trial looks at whether a device stimulates the body to relax, reducing stress and improving heart health.

Who is the study for?

This trial is for girls aged 12-18, with or without chronic nausea, abdominal pain, dyspepsia, or irritable bowel syndrome. They must be able to stand upright and not have skin issues on the ear, epilepsy, heart devices like pacemakers, severe circulation problems in legs, hernias, pregnancy or unstable conditions like kidney disease.Check my eligibility

What is being tested?

The study tests if a TENS unit (a device that uses electric current) applied to the ear can increase heart rate variability (HRV), which might help manage gastrointestinal symptoms by affecting nerve signals.See study design

What are the potential side effects?

Potential side effects of using a TENS unit may include local irritation at the site of application and discomfort from the electrical stimulation. There's also a risk of fainting or dizziness during HRV recording.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline and 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline and 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and 4 weeks. 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 high-frequency heart rate variability (hfHRV) at 4 weeks

Rate of compliance with daily TENS usage

Rate of feasibility with daily TENS usage

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-FGIDExperimental Treatment1 Intervention

Patients without a FGID

Group II: FGIDExperimental Treatment1 Intervention

Patients with a FGID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS Unit

2010

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,945 Total Patients Enrolled

Gisela Chelimsky, MDPrincipal InvestigatorVCU

2 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

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

Is there a specific demographic this experiment is targeting?

"To be eligible to partake in this medical trial, individuals must have a functional gastrointestinal disorder and fall between the ages of 12 and 18. Around 100 participants will be accepted into the study."

Answered by AI

What is the upper age limit for those eligible to take part in this clinical trial?

"The requirements for this particular trial demand that potential participants be between 12 and 18 years of age. There are 23 trials specifically aimed at minors, whereas 56 clinical studies target adults over the age of 65."

Answered by AI

Are there any remaining vacancies for participants in this research study?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical study, first published on October 18th 2023 and recently updated a day later, is currently open for recruitment of approximately 100 patients from 1 location."

Answered by AI

How many participants are being accepted for this research project?

"Affirmative. Clinicaltrials.gov demonstrates that this research is actively recruiting, having been initially posted on October 18th 2023 and updated as recently as the 19th of the same month. 100 patients are needed from a single trial site for completion."

Answered by AI

Recent research and studies

Journal of Pain ResearchJournal

Heart Rate Variability as a Biomarker for Autonomic Nervous System Response Differences Between Children with Chronic Pain and Healthy Control Children

Tsao, Jennie, Subhadra Evans, Laura Seidman, Lung, Lonnie Zeltzer, and Bruce Naliboff. 2013. “Heart Rate Variability as a Biomarker for Autonomic Nervous System Response Differences Between Children with Chronic Pain and Healthy Control Children”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s43849.

clinicaltrials.govStudy

Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

2023. "Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987813.