Transcutaneous Electrical Acustimulation (TEA) for Constipation

University of Michigan, Ann Arbor, MI
Constipation+1 More ConditionsTranscutaneous Electrical Acustimulation (TEA) - Device
Eligibility
18 - 99
All Sexes

Study 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

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: VAS surveys will be taken 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Week 3
Change in pressure of maximum tolerance in mmHg of the rectum as measured by a barostat device when compared to other modalities (body position, frequency and sham)
Change in pressure of maximum tolerance in mmHg of the rectum as measured by a barostat device when compared to pre-TEA administration.
Week 3
Change in pain as measured by Visual Analog Scale (VAS) surveys when compared to other modalities (body position, frequency and sham)
Change in pain as measured by Visual Analog Scale (VAS) surveys when compared to pre-TEA administration.

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Subjects with IBS-C
1 of 1

Experimental Treatment

23 Total Participants · 1 Treatment Group

Primary Treatment: Transcutaneous Electrical Acustimulation (TEA) · No Placebo Group · N/A

Subjects with IBS-C
Device
Experimental Group · 1 Intervention: Transcutaneous Electrical Acustimulation (TEA) · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Acustimulation (TEA)
2021
N/A
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: vas surveys will be taken 6 times approximately 5 minutes apart during each visit. 5 visits will occur between 1 and 3 weeks apart.

Who is running the clinical trial?

University of MichiganLead Sponsor
1,673 Previous Clinical Trials
6,422,248 Total Patients Enrolled
6 Trials studying Constipation
691 Patients Enrolled for Constipation
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,611,195 Total Patients Enrolled
3 Trials studying Constipation
956 Patients Enrolled for Constipation
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,281 Previous Clinical Trials
458,053 Total Patients Enrolled
1 Trials studying Constipation
160 Patients Enrolled for Constipation
Transtimulation Research, IncOTHER
1 Previous Clinical Trials
26 Total Patients Enrolled
Jiande Chen, Ph.D.Principal InvestigatorUniversity of Michigan

Eligibility Criteria

Age 18 - 99 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.