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This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.
In understanding the pathophysiology of pediatric functional gastrointestinal disorders (FGID), it has been documented that subjects have decreased vagal tone. Vagal tone in turn modulates mitochondrial bioenergetics and plays a role in anti inflammatory effects. Further defining these brain-body connections that underlie FGID's could help guide future treatment.
The investigators postulate that a 4 week neuro-stimulation with an Electro Auricular Device that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics and decrease in inflammatory markers in this patient group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous neurostimulation | Experimental | Subjects will have 4 weeks of active therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous neurostimulation | Device | Percutaneous neurostimulation using NSS-2 Bridge device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher. | Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12) |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure Heart Rate Variability | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12) |
| To Measure Functional Disability Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisela Chelimsky, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25378088 | Background | He X, Zhao M, Bi X, Sun L, Yu X, Zhao M, Zang W. Novel strategies and underlying protective mechanisms of modulation of vagal activity in cardiovascular diseases. Br J Pharmacol. 2015 Dec;172(23):5489-500. doi: 10.1111/bph.13010. Epub 2015 Jan 13. | |
| 28826627 | Background | 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. |
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recruited form the pediatric neurogastrointestinal clinic, from 2/6/2019 to 5/23/2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Only Active Devise, Open Label | active devise, 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Percutaneous Neurostimulation | Subjects will have 4 weeks of active therapy. Percutaneous neurostimulation: Percutaneous neurostimulation using NSS-2 Bridge device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher. | Per protocol maximal respiration data was collected for patients at baseline, after completing all 4 weeks of NSS Bridge Neurostim therapy and long term follow up post therapy. | Posted | Mean | Standard Deviation | pmol/min | Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12) |
|
Through study completion, an average of 4 weeks, including 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 | Only Active Device, Open Label | active device, 4 weeks | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gisela Chelimsky, MD | Medical College of Wisconsin | 414-266-3690 | gchelimsky@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 | Nov 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D043183 | Irritable Bowel Syndrome |
| D004415 | Dyspepsia |
| D001342 | Autonomic Nervous System Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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All subjects will receive the same electro auricular device
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The Functional Disability Inventory (FDI) questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4. Scale:0-No trouble
Higher scores (4) indicate more difficulty functioning due to physical health. The total score ranges from 0 to 60 among 15 questions. The individual score for all 15 questions are added together for the total score. If all 15 questions are answered as 0- no trouble then the total score would be 0 (lowest difficulty). If all 15 questions are answered as 4-Impossible, then the total score would be 60 (highest difficulty). An assortment of answers will fall within this 0-60 range depending on the difficulty level answer for each question. |
| At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12) |
| 23927739 | Background | Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate variability: a meta-analysis. J Dig Dis. 2013 Dec;14(12):638-46. doi: 10.1111/1751-2980.12092. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Secondary | To Measure Heart Rate Variability | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. | Posted | Mean | Standard Deviation | Beats per minute | At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12) |
|
|
|
| Secondary | To Measure Functional Disability Inventory | The Functional Disability Inventory (FDI) questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4. Scale:0-No trouble
Higher scores (4) indicate more difficulty functioning due to physical health. The total score ranges from 0 to 60 among 15 questions. The individual score for all 15 questions are added together for the total score. If all 15 questions are answered as 0- no trouble then the total score would be 0 (lowest difficulty). If all 15 questions are answered as 4-Impossible, then the total score would be 60 (highest difficulty). An assortment of answers will fall within this 0-60 range depending on the difficulty level answer for each question. | Posted | Mean | Standard Deviation | score on a scale | At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12) |
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| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
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