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Home Transcutaneous Electrical Acustimulation (TEA)

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllUniversity of Michigan
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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).
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What it tests

  • TEA
  • Lexapro
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Where

1 site
University of Michigan
Ann Arbor, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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