Home Transcutaneous Electrical Acustimulation (TEA)

NCT05519683 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: HUM002173015UH3NS115108-04
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome With Constipation

Keywords

Irritable Bowel Syndrome with Constipation; Constipation; Irritable Bowel Syndrome; Colon, Irritable; Irritable Colon

Outcome Measures

Primary Outcomes (2)

• 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.

  Daily for 14 weeks

• 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.

  Weekly for 14 weeks

Secondary Outcomes (9)

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

  Weekly for 14 weeks

• Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety

  Weekly for 14 weeks

• Change in Hospital Anxiety and Depression Scale (HADS) - Depression

  Weekly for 14 weeks

• Change in IBS - Symptom Severity Score (IBS-SSS)

  Once every 10 days for 14 weeks

• Daily Stool Diary - Change in number of bowel movements

  Daily for 14 weeks

Study Arms (4)

TEA at location A

EXPERIMENTAL

The 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.

Device: TEA

TEA at location B

SHAM COMPARATOR

The 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.

Device: TEA

TEA at location C

EXPERIMENTAL

The 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.

Device: TEA

Escitalopram treatment

EXPERIMENTAL

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.

Drug: Lexapro

Interventions

TEA DEVICE

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.

Also known as: Transcutaneous Electrical Acustimulation

TEA at location A; TEA at location B; TEA at location C

Lexapro DRUG

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.

Also known as: escitalopram

Escitalopram treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 25989154 BACKGROUND

• 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.

  PMID: 24657460 BACKGROUND

• 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.

  PMID: 28915981 BACKGROUND

• 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.

  PMID: 31347247 BACKGROUND

• 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.

  PMID: 29925916 BACKGROUND

MeSH Terms

Conditions

Constipation; Irritable Bowel Syndrome

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Borko Nojkov, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Burnett

CONTACT

734-647-2806; bucolin@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: One quarter of participants will be in each arm. Those randomized to device arms will not be informed of their parameters. Those in the drug arm will be informed of their arm soon after randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Specialty Gastroenterology, Internal Medicine

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 29, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)