Clinical trial NCT05519683: Home Transcutaneous Electrical Acustimulation (TEA)
Official title: Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: Irritable Bowel Syndrome with Constipation
Constipation
Irritable Bowel Syndrome
Colon, Irritable
Irritable Colon
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-08-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the participants will be divided into 4 treatment groups designed to investigate the feasibility of TEA using optimized parameters in comparison with medical neuromodulation therapy (escitalopram) and sham-TEA. The treatment will be home-based and last for a period of 8 weeks. To preserve scientific integrity and effective masking, certain details of arms and interventions will be made more precise upon or prior to reporting results

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).

Primary outcomes:
measure: Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
timeFrame: Daily for 14 weeks
measure: Change in global abdominal pain
timeFrame: Weekly for 14 weeks
Secondary outcomes:
measure: Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey
timeFrame: Weekly for 14 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety
timeFrame: Weekly for 14 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) - Depression
timeFrame: Weekly for 14 weeks
measure: Change in IBS - Symptom Severity Score (IBS-SSS)
timeFrame: Once every 10 days for 14 weeks
measure: Daily Stool Diary - Change in number of bowel movements
timeFrame: Daily for 14 weeks
measure: Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS)
timeFrame: Daily for 14 weeks
measure: Daily Stool Diary - Change in abdominal bloating
timeFrame: Daily for 14 weeks
measure: Daily Stool Diary - Change sense of urgency
timeFrame: Daily for 14 weeks
measure: Change in Bowel Habits Per Separate IBS-SSS Survey
timeFrame: Once every 10 days for 14 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Borko Nojkov, MD
role: PRINCIPAL_INVESTIGATOR
References:
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