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| ID | Type | Description | Link |
|---|---|---|---|
| 5UH3NS115108-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEA at location A | Experimental | The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. 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. |
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| TEA at location B | Sham Comparator | The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. 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. |
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| TEA at location C | Experimental | The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. 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. |
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| Escitalopram treatment | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey | Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14. | Daily for 14 weeks |
| Change in global abdominal pain | Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied). These answers will be compared from week 1 to week 14. | Weekly for 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey | A self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. This survey is 34 questions, all scored from 1 to 5, with 1 being the lowest (not at all) and 5 being the highest (a great deal, or extremely). The individual responses to the 34 items are summed and averaged for a total score. These answers will be compared from week 0 to week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colin Burnett | Contact | 734-647-2806 | bucolin@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Borko Nojkov, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25989154 | Background | Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738. | |
| 24657460 | Background | Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20. |
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De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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One quarter of participants will be in each arm. Those randomized to device arms will not be informed of their parameters. Those in the drug arm will be informed of their arm soon after randomization.
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| Lexapro | Drug | 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. |
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| Weekly for 14 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety | Determines levels of anxiety that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14 | Weekly for 14 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) - Depression | Determines levels of depression that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14 | Weekly for 14 weeks |
| Change in IBS - Symptom Severity Score (IBS-SSS) | A survey designed to record and monitor the severity of IBS. The maximum achievable score was 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively. Scores will be compared from day 10 to day 90 | Once every 10 days for 14 weeks |
| Daily Stool Diary - Change in number of bowel movements | The Daily Stool Diary will ask how many bowel movements have occurred in the past 24 hours. This will also ask to indicate the number of spontaneous bowel movements (a bowel movement which occurs without use of rescue medications or maneuvers) and number of complete spontaneous bowel movements (a bowel movement which is associated with a feeling of complete evacuation) The change in the mean daily number of bowel movements will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period. | Daily for 14 weeks |
| Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS) | The Daily Stool Diary will use the BSFS to evaluate the stool consistency for each of the bowel movements in the past 24 hours. The BSFS is scored from 1 to 7, which are defined as follows: BSFS Type 1: Separate hard lumps, like nuts BSFS Type 2: Sausage-shaped but lumpy BSFS Type 3: Like a sausage but with cracks on its surface BSFS Type 4: Like a sausage or snake, smooth and soft BSFS Type 5: Soft blobs with clear-cut edges BSFS Type 6: Fluffy pieces with ragged edges, a mushy stool BSFS Type 7: watery, no solid pieces, entirely liquid The change in the mean daily scores for Bristol Stool Form Scale will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period. | Daily for 14 weeks |
| Daily Stool Diary - Change in abdominal bloating | The Daily Stool Diary will rate the severity of participants abdominal bloating over past 24 hours on a visual analog scale for bloating (0-10 scale), with 0 being the lowest (no bloating) and 10 being the highest (worst imaginable bloating) The change in the mean daily scores for abdominal bloating will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period. | Daily for 14 weeks |
| Daily Stool Diary - Change sense of urgency | The Daily Stool Diary will assess the sense of urgency with the following question: "Have you felt or experienced a sense of urgency today?" which will be answered with a yes or no. The change in the most frequent daily scores for sense of urgency will be calculated over 1 week and compared between the phase-in period and the final week of the treatment period. | Daily for 14 weeks |
| Change in Bowel Habits Per Separate IBS-SSS Survey | This survey (a part of the IBS-SSS which is not factored into the scoring) contains 9 questions asking about bowel habits. This will question the minimum and maximum number of bowel movements per day/week/month, typical location of pain, the effect of IBS pain on work habits. Responses will be compared from day 10 to day 90 | Once every 10 days for 14 weeks |
| 28915981 | Background | Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30. |
| 31347247 | Background | Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26. |
| 29925916 | Background | Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21. |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |