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Irritable Bowel Syndrome With ConstipationPhase 2/3Home-TEANCT05519683

Home Transcutaneous Electrical Acustimulation (TEA)

A Phase 2/3 study testing TEA and Lexapro in people with Irritable Bowel Syndrome With Constipation, run by University of Michigan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TEA and Lexapro
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteUnited States
Study dates
2 Nov 2022to Mar 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
  • Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period
  • Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis.
  • Abdominal pain is not adequately relieved at the time of screening and the time of randomization.

Who cannot join

  • Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
  • Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation.
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
  • A history of abdominal surgery (other than cholecystectomy or appendectomy)
  • Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (>2 days/week) use of opioid or antispasmodic medication. Those who frequently use Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) will also be excluded.
  • Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs). Individuals on chronic SSRI therapy, including escitalopram, at the initial evaluation will not be enrolled in the study.
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  • Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. - - Participants will be informed that MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram.
  • Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations.
  • Known allergy to adhesive Electrocardiogram (ECG) electrodes.
  • Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts.
  • Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colin Burnett contact

734-647-2806

bucolin@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Colin Burnett, 734-647-2806, bucolin@med.umich.edu

    Recruiting

Other trials in United States

About this study

Official title: Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

Read the detailed description

The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the participants will be divided into 4 treatment groups designed to investigate the feasibility of TEA using optimized parameters in comparison with medical neuromodulation therapy (escitalopram) and sham-TEA. The treatment will be home-based and last for a period of 8 weeks. To preserve scientific integrity and effective masking, certain details of arms and interventions will be made more precise upon or prior to reporting results

Being tested
TEA, Lexapro
Keywords
Irritable Bowel Syndrome with Constipation, Constipation, Irritable Bowel Syndrome, Colon, Irritable, Irritable Colon
Medical subject headings
Constipation, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEADevice

    Also called Transcutaneous Electrical Acustimulation

    The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.

  • LexaproDrug

    Also called escitalopram

    This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.

Study groups in NCT05519683
Study groupRoleWhat they receive
TEA at location AExperimentalThe TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Receives: Device: TEA
TEA at location BSham comparatorThe TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Receives: Device: TEA
TEA at location CExperimentalThe TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Receives: Device: TEA
Escitalopram treatmentExperimentalThis arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
Receives: Drug: Lexapro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey

    Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain)

    These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.

    Measured: Daily for 14 weeks

  2. Change in global abdominal pain

    Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied).

    These answers will be compared from week 1 to week 14.

    Measured: Weekly for 14 weeks

Secondary outcomes (9)

  1. Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey

    A self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. This survey is 34 questions, all scored from 1 to 5, with 1 being the lowest (not at all) and 5 being the highest (a great deal, or extremely). The individual responses to the 34 items are summed and averaged for a total score.

    These answers will be compared from week 0 to week 14

    Measured: Weekly for 14 weeks

  2. Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety

    Determines levels of anxiety that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges.

    0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal

    Scores will be compared from week 0 to week 14

    Measured: Weekly for 14 weeks

  3. Change in Hospital Anxiety and Depression Scale (HADS) - Depression

    Determines levels of depression that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges.

    0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal

    Scores will be compared from week 0 to week 14

    Measured: Weekly for 14 weeks

  4. Change in IBS - Symptom Severity Score (IBS-SSS)

    A survey designed to record and monitor the severity of IBS. The maximum achievable score was 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively.

    Scores will be compared from day 10 to day 90

    Measured: Once every 10 days for 14 weeks

  5. Daily Stool Diary - Change in number of bowel movements

    The Daily Stool Diary will ask how many bowel movements have occurred in the past 24 hours. This will also ask to indicate the number of spontaneous bowel movements (a bowel movement which occurs without use of rescue medications or maneuvers) and number of complete spontaneous bowel movements (a bowel movement which is associated with a feeling of complete evacuation)

    The change in the mean daily number of bowel movements will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.

    Measured: Daily for 14 weeks

  6. Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS)

    The Daily Stool Diary will use the BSFS to evaluate the stool consistency for each of the bowel movements in the past 24 hours. The BSFS is scored from 1 to 7, which are defined as follows:

    BSFS Type 1: Separate hard lumps, like nuts BSFS Type 2: Sausage-shaped but lumpy BSFS Type 3: Like a sausage but with cracks on its surface BSFS Type 4: Like a sausage or snake, smooth and soft BSFS Type 5: Soft blobs with clear-cut edges BSFS Type 6: Fluffy pieces with ragged edges, a mushy stool BSFS Type 7: watery, no solid pieces, entirely liquid

    The change in the mean daily scores for Bristol Stool Form Scale will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.

    Measured: Daily for 14 weeks

  7. Daily Stool Diary - Change in abdominal bloating

    The Daily Stool Diary will rate the severity of participants abdominal bloating over past 24 hours on a visual analog scale for bloating (0-10 scale), with 0 being the lowest (no bloating) and 10 being the highest (worst imaginable bloating)

    The change in the mean daily scores for abdominal bloating will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.

    Measured: Daily for 14 weeks

  8. Daily Stool Diary - Change sense of urgency

    The Daily Stool Diary will assess the sense of urgency with the following question: "Have you felt or experienced a sense of urgency today?" which will be answered with a yes or no.

    The change in the most frequent daily scores for sense of urgency will be calculated over 1 week and compared between the phase-in period and the final week of the treatment period.

    Measured: Daily for 14 weeks

  9. Change in Bowel Habits Per Separate IBS-SSS Survey

    This survey (a part of the IBS-SSS which is not factored into the scoring) contains 9 questions asking about bowel habits. This will question the minimum and maximum number of bowel movements per day/week/month, typical location of pain, the effect of IBS pain on work habits.

    Responses will be compared from day 10 to day 90

    Measured: Once every 10 days for 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start2 Nov 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519683
Sponsor's protocol ID
HUM00217301
Other IDs
5UH3NS115108-04
Acronym
Home-TEA
Status last verified
Sep 2026
First submitted
18 Aug 2022
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared

Publications

  • Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738.

    PubMed 25989154

  • Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.

    PubMed 24657460

  • Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.

    PubMed 28915981

  • Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.

    PubMed 31347247

  • Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.

    PubMed 29925916

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TEA and Lexapro in people with Irritable Bowel Syndrome With Constipation, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Colin Burnett (734-647-2806, bucolin@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey (time frame: Daily for 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05519683, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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