Home Transcutaneous Electrical Acustimulation (TEA)
Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
University of Michigan
160 participants
Nov 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria11
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05519683