Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C (TEA Trial)

N/A

Waitlist Available

Led By Jiande Chen, Ph.D.

Research Sponsored by University of Michigan

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 baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. between each of 5 sessions, participants had 1-3 weeks off.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different combinations of electrical stimulations to the wrist or knee to see which is most effective at treating IBS-C.

Eligible Conditions

Constipation
Irritable Bowel Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities.

Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.

Secondary study objectives

Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment.

Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.

Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration.

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with IBS-CExperimental Treatment1 Intervention

All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Acustimulation (TEA)

2021

N/A

~30

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