Home Transcutaneous Electrical Acustimulation (TEA)

Launched by UNIVERSITY OF MICHIGAN · Aug 24, 2022

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ClinConnect Summary

This clinical trial is looking at a new way to help people with Irritable Bowel Syndrome with Constipation (IBS-C) manage their abdominal pain. The study is testing two different treatments: one involves a device that uses gentle electrical signals (called Transcutaneous Electrical Acustimulation or TEA), and the other is a medication called escitalopram (often known by the brand name Lexapro). Participants will be compared to a control group that does not receive the actual treatment, to see which method is more effective in reducing pain.

To participate in this study, individuals should be between the ages of 65 and 74 and must have ongoing symptoms of IBS-C, including significant abdominal pain at least once a week for the past three months. However, people with certain other health conditions, those who are pregnant or breastfeeding, and individuals taking specific medications will not be eligible to join. Participants can expect to receive the treatments at home and will be closely monitored throughout the study. It's important for anyone considering joining this trial to understand the eligibility criteria and to communicate with the study team about any existing health conditions or medications they are taking.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).