Dyspepsia, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
Conditions
Keywords
FGID, Neural Stimulation, Functional Abdominal Pain, Dysautonomia
Brief summary
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.
Detailed description
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.
Interventions
Percutaneous neurostimulation using NSS-2 Bridge device
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive the same electro auricular device
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms * Subjects will meet Rome IV criteria for functional nausea, irritable bowel syndrome, dyspepsia or functional abdominal pain as determined by a pediatric gastroenterologist * Patients must have an intact external ear that is free of infection or severe dermatological conditions, have stable vital signs for their respective age, no history of seizures and no currently implanted electrical device
Exclusion criteria
* Mental retardation or pervasive developmental disorder or epilepsy * Psychosis * Genetic or chromosomal disorders * Pregnancy * Subjects who admit to substance abuse during screening * Patients with findings of peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, or any chronic condition or medication that may cause nausea or pain * Patients who are treated with opioids or who had any changes in their medical regimen in the past four weeks prior to study * Patients with a history of allergy to adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Measure Heart Rate Variability | At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12) | EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control. |
| To Measure Functional Disability Inventory | At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12) | 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 1. A little trouble 2. Some Trouble 3. A lot of Trouble 4. Impossible 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. |
Countries
United States
Participant flow
Recruitment details
recruited form the pediatric neurogastrointestinal clinic, from 2/6/2019 to 5/23/2019
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Neurostimulation Subjects will have 4 weeks of active therapy.
Percutaneous neurostimulation: Percutaneous neurostimulation using NSS-2 Bridge device | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Percutaneous Neurostimulation | — |
|---|---|---|
| Age, Categorical <=18 years | 7 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Only Active Devise, Open Label | To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Week 1 | 221.85 pmol/min | Standard Deviation 195.35 |
| Only Active Devise, Open Label | To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Week 4 | 151.14 pmol/min | Standard Deviation 101.97 |
| Only Active Devise, Open Label | To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity | Week 8 | 139.20 pmol/min | Standard Deviation 120.12 |
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 1. A little trouble 2. Some Trouble 3. A lot of Trouble 4. Impossible 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.
Time frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Only Active Devise, Open Label | To Measure Functional Disability Inventory | Week 1 | 26.53 score on a scale | Standard Deviation 14.04 |
| Only Active Devise, Open Label | To Measure Functional Disability Inventory | Week 4 | 24.58 score on a scale | Standard Deviation 15.25 |
| Only Active Devise, Open Label | To Measure Functional Disability Inventory | Week 8 | 22.70 score on a scale | Standard Deviation 17.47 |
| Only Active Devise, Open Label | To Measure Functional Disability Inventory | Total | 24.74 score on a scale | Standard Deviation 14.6 |
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.
Time frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Only Active Devise, Open Label | To Measure Heart Rate Variability | Week 1 | 100.31 Beats per minute | Standard Deviation 17.31 |
| Only Active Devise, Open Label | To Measure Heart Rate Variability | Week 4 | 97.27 Beats per minute | Standard Deviation 21.69 |
| Only Active Devise, Open Label | To Measure Heart Rate Variability | Week 8 | 93.86 Beats per minute | Standard Deviation 15.63 |
| Only Active Devise, Open Label | To Measure Heart Rate Variability | Total | 97.35 Beats per minute | Standard Deviation 18.17 |