Home Transcutaneous Electrical Acustimulation (TEA)
A legfontosabb adatok
- Hol
- Ann Arbor (Egyesült Államok)A helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- University of MichiganAnn Arbor, Egyesült ÁllamokContact: Colin BurnettRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Michigan
- Azonosító
- NCT05519683
- A regiszteradat frissítve
- 2026. szeptember 17.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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 angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts; Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease; 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); Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations; Known allergy to adhesive Electrocardiogram (ECG) electrodes; Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above); 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.