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Behavioural Intervention

Transcutaneous Electrical Acustimulation (TEA) for Constipation (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

TEA Trial 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

TEA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

TEA 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

7,492,574 Total Patients Enrolled

3 Trials studying Constipation

956 Patients Enrolled for Constipation

University of MichiganLead Sponsor

1,796 Previous Clinical Trials

6,377,930 Total Patients Enrolled

7 Trials studying Constipation

800 Patients Enrolled for Constipation

Transtimulation Research, IncOTHER

2 Previous Clinical Trials

46 Total Patients Enrolled

Frequently Asked Questions

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

Does this medical trial require additional participants at present?

"According to clinicaltrials.gov, this research is presently recruiting participants. The trial was first published on the 1st of July 2021 and has since been updated most recently on the 30th of November 2022."

Answered by AI

What criteria must an individual meet to qualify for participation in this research?

"Currently, the trial is attempting to source 25 individuals suffering from dyschezia aged between 18 and 99. To be eligible, they must agree to abide by all rules set out in the study, meet diagnostic criteria for IBS-C according to Rome IV standards, demonstrate a minimum of 3 months of associated symptoms before enrollment, report inadequate relief from their abdominal pain at both screening and randomization stages, as well as possess a VAS pain score higher than 3/10."

Answered by AI

How many participants are being recruited to partake in this clinical trial?

"Affirmative. The clinical trial portal provides evidence that this medical research, which was originally published on 1st July 2021, is currently recruiting. 25 patients are being sought from a single site."

Answered by AI

Does this trial accept individuals older than 45 years of age?

"This clinical trial is available to applicants aged 18-99. Patients under the age of 18 have 24 trials they can participate in, while those over 65 have 72 options."

Answered by AI

Recent research and studies

NeuroscienceJournal

Cerebral Blood Flow-based Evidence for Mechanisms of Low- Versus High-frequency Transcutaneous Electric Acupoint Stimulation Analgesia: A Perfusion Fmri Study in Humans

Jiang, Y., J. Liu, J. Liu, J. Han, X. Wang, and C. Cui. 2014. “Cerebral Blood Flow-based Evidence for Mechanisms of Low- Versus High-frequency Transcutaneous Electric Acupoint Stimulation Analgesia: A Perfusion Fmri Study in Humans”. Neuroscience. Elsevier BV. doi:10.1016/j.neuroscience.2014.03.019.

ExploreJournal

Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of in Vitro Fertilization: A Prospective, Randomized and Controlled Study

Qu, Fan, Fang-Fang Wang, Yan Wu, Jue Zhou, Nicola Robinson, Paul J. Hardiman, Jie-Xue Pan, et al.. 2017. “Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of in Vitro Fertilization: A Prospective, Randomized and Controlled Study”. Explore. Elsevier BV. doi:10.1016/j.explore.2017.06.004.

Neuromodulation: Technology at the Neural InterfaceJournal

Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined with Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway

Yu, Yue, Ruiling Wei, Zhi Liu, Jiaqin Xu, Chao Xu, and Jiande D.Z. Chen. 2019. “Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined with Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.13021.

American Journal of GastroenterologyJournal