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| Name | Class |
|---|---|
| American Neurogastroenterology and Motility Society | OTHER |
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This study evaluates the effectiveness of a neurostimulator applied to the outer ear for adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve stimulation to a branch of the vagus nerve which is thought to be involved in transmission of pain signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.
The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous system. It is thought to carry signals of discomfort and nausea to the brain where it is interpreted. The autonomic nervous system may be in imbalance in patients with functional gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional abdominal pain with or without nausea.
Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored weekly for the entire study as well as after the study is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurostimulator | Experimental | Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks |
|
| Sham Neurostimulator | Sham Comparator | Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulator | Device | Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Frequency-Severity-Duration Scale (PFSD) Score | One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome. | Change from Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Profile | Two page, 17-item questionnaire which measures the subjective experience of nausea on a scale from 0 (not at all) to 9 (severely) across three dimensions: 1) somatic distress; 2) gastrointestinal distress and 3) emotional distress. Total score 153. | Change from Baseline to week 4 in Nausea Profile score. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses | Nine-page, validated, parent-report questionnaire that assesses symptoms associated with pediatric functional GI disorders to diagnose the following specific Rome III criteria: Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, Functional Abdominal Pain and Functional Abdominal Pain Syndrome. The number of participants with these specific diagnoses at baseline were reported, including overlapping diagnoses. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Kovacic, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16679325 | Result | Sator-Katzenschlager SM, Wolfler MM, Kozek-Langenecker SA, Sator K, Sator PG, Li B, Heinze G, Sator MO. Auricular electro-acupuncture as an additional perioperative analgesic method during oocyte aspiration in IVF treatment. Hum Reprod. 2006 Aug;21(8):2114-20. doi: 10.1093/humrep/del110. Epub 2006 May 5. | |
| 14570667 | Result |
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Subjects were excluded if there were any changes to their current medications or any new medications added during the two weeks prior to study start. Any subject with a new diagnosis of an organic medical condition was also excluded.
Eligible subjects ages 11-18 years, recruited from the outpatient Gastroenterology clinic at the Children's Hospital of Wisconsin between September 2015 and November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurostimulator | Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks. |
| FG001 | Sham Neurostimulator | Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Sham: Inactive neurostimulator device (without electrical charge), worn for 5 days each week x 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurostimulator | Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks. |
| BG001 | Sham Neurostimulator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Frequency-Severity-Duration Scale (PFSD) Score | One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome. | Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method. | Posted | Median | Inter-Quartile Range | units on a scale | Change from Baseline to Week 4 |
|
1.5 years (during time of subject participation and through follow-up period)
Information on any adverse events were systematically collected by the research staff at each visit prior to placement of a new neurostimulator and at the follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurostimulator | Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Neurostimulator: Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katja Kovacic | Medical College of Wisconsin | 4142663915 | kkovacic@mcw.edu |
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| ID | Term |
|---|---|
| D058542 | Implantable Neurostimulators |
| ID | Term |
|---|---|
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Sham | Device | Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks. |
|
| State-Trait Anxiety Inventory for Children (STAI-C) |
State-Trait Anxiety Inventory for Children (STAI-C). State anxiety measured by 20-item questionnaire assessing anxiety at a particular moment in time on a 3-point rating scale. Raw scores (range 20-60) were converted to normalized T-Scores based on a population of healthy school children (mean=50; standard deviation=10) with higher score indicating worse outcome. Effects of intervention on state anxiety was assessed before (pre) and after (post) therapy. |
| Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7) | A 7-item instrument that measures quality of life in relation to health. Each question has five response options (scored 1-5 units on a scale). A total raw sum score is generated, ranging from lowest score of 7 and highest score of 35 with higher scores indicating better outcome (improved quality of life). The raw score is converted to a standardized T-score (mean=50; standard deviation=10) based on a population of healthy children. T-scores were compared before (Pre) and after (Post) treatment intervention. | Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
| Functional Disability Inventory (FDI) | 15-item instrument, each question rated on a five-point scale (0="no trouble" to 4="impossible"), indicating how much difficulty subjects have doing common childhood activities because of their physical health. A total score is summed (range 0-60) with higher score indicating worse outcome (greater pain-related disability). Scored were compared before (Pre) and after (Post) treatment intervention. | Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
| Baseline only (diagnostic criteria) |
| Sator-Katzenschlager SM, Szeles JC, Scharbert G, Michalek-Sauberer A, Kober A, Heinze G, Kozek-Langenecker SA. Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain: a pilot study. Anesth Analg. 2003 Nov;97(5):1469-1473. doi: 10.1213/01.ANE.0000082246.67897.0B. |
| 20954963 | Result | Asher GN, Jonas DE, Coeytaux RR, Reilly AC, Loh YL, Motsinger-Reif AA, Winham SJ. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med. 2010 Oct;16(10):1097-108. doi: 10.1089/acm.2009.0451. |
| 22621941 | Result | Busch V, Zeman F, Heckel A, Menne F, Ellrich J, Eichhammer P. The effect of transcutaneous vagus nerve stimulation on pain perception--an experimental study. Brain Stimul. 2013 Mar;6(2):202-9. doi: 10.1016/j.brs.2012.04.006. Epub 2012 May 7. |
| 23453934 | Result | Kraus T, Kiess O, Hosl K, Terekhin P, Kornhuber J, Forster C. CNS BOLD fMRI effects of sham-controlled transcutaneous electrical nerve stimulation in the left outer auditory canal - a pilot study. Brain Stimul. 2013 Sep;6(5):798-804. doi: 10.1016/j.brs.2013.01.011. Epub 2013 Feb 13. |
| 15105215 | Result | Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, Szeles JC, Finster G, Schiesser AW, Heinze G, Kress HG. The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg. 2004 May;98(5):1359-64, table of contents. doi: 10.1213/01.ane.0000107941.16173.f7. |
| 31622740 | Derived | Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14. |
| 28826627 | Derived | Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18. |
| Withdrawal by Subject |
|
Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Sham Neurostimulator | Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks. |
|
|
|
| Secondary | Nausea Profile | Two page, 17-item questionnaire which measures the subjective experience of nausea on a scale from 0 (not at all) to 9 (severely) across three dimensions: 1) somatic distress; 2) gastrointestinal distress and 3) emotional distress. Total score 153. | Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method. | Posted | Median | Inter-Quartile Range | units on a scale | Change from Baseline to week 4 in Nausea Profile score. |
|
|
|
| Secondary | State-Trait Anxiety Inventory for Children (STAI-C) | State-Trait Anxiety Inventory for Children (STAI-C). State anxiety measured by 20-item questionnaire assessing anxiety at a particular moment in time on a 3-point rating scale. Raw scores (range 20-60) were converted to normalized T-Scores based on a population of healthy school children (mean=50; standard deviation=10) with higher score indicating worse outcome. Effects of intervention on state anxiety was assessed before (pre) and after (post) therapy. | Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method. | Posted | Median | Inter-Quartile Range | T-score | Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7) | A 7-item instrument that measures quality of life in relation to health. Each question has five response options (scored 1-5 units on a scale). A total raw sum score is generated, ranging from lowest score of 7 and highest score of 35 with higher scores indicating better outcome (improved quality of life). The raw score is converted to a standardized T-score (mean=50; standard deviation=10) based on a population of healthy children. T-scores were compared before (Pre) and after (Post) treatment intervention. | Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method. | Posted | Median | Inter-Quartile Range | T-score | Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
|
|
|
| Secondary | Functional Disability Inventory (FDI) | 15-item instrument, each question rated on a five-point scale (0="no trouble" to 4="impossible"), indicating how much difficulty subjects have doing common childhood activities because of their physical health. A total score is summed (range 0-60) with higher score indicating worse outcome (greater pain-related disability). Scored were compared before (Pre) and after (Post) treatment intervention. | Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method. | Posted | Median | Inter-Quartile Range | units on a scale | Change from Baseline (Pre) to 2-3 months after end of therapy (Post) |
|
|
|
| Other Pre-specified | Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses | Nine-page, validated, parent-report questionnaire that assesses symptoms associated with pediatric functional GI disorders to diagnose the following specific Rome III criteria: Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, Functional Abdominal Pain and Functional Abdominal Pain Syndrome. The number of participants with these specific diagnoses at baseline were reported, including overlapping diagnoses. | Posted | Count of Participants | Participants | Baseline only (diagnostic criteria) |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 4 |
| 57 |
| EG001 | Sham Neurostimulator | Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks Sham: Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks. | 0 | 47 | 0 | 47 | 6 | 47 |
| Adhesive allergy | Immune system disorders | MedDRA (10.0) | Systematic Assessment | localized skin irritation |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | triggered by needle phobia |
|
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| D019736 | Prostheses and Implants |
| Abdominal Migraine |
|
| Functional Abdominal Pain |
|