Functional Gastrointestinal DisordersNCT03931330
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
A study testing Percutaneous neurostimulation in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia
- What is being tested?
- Percutaneous neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain Syndrome
- Being tested
- Percutaneous neurostimulation
- Keywords
- FGID, Neural Stimulation, Functional Abdominal Pain, Dysautonomia
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome, Dyspepsia, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous neurostimulationDevice
Also called NSS-2 Bridge by Innovative Health Solutions
Percutaneous neurostimulation using NSS-2 Bridge device
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous neurostimulation | Experimental | Subjects will have 4 weeks of active therapy. Receives: Device: Percutaneous neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)
Secondary outcomes (2)
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.
Measured: 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
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
- A little trouble
- Some Trouble
- A lot of Trouble
- 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.
Measured: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start6 Feb 2019
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive the same electro auricular device
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelimsky, Gisela Grotewold, Medical College of Wisconsin
- Investigators
- Gisela Chelimsky, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931330
- Sponsor's protocol ID
- 1101710
- Status last verified
- May 2021
- First submitted
- 22 Apr 2019
- Last updated
- 21 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25378088Kovacic 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.
PubMed 28826627Liu 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.
PubMed 23927739
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
- ClinicalTrials.gov ID
- NCT03931330
- Acronym / sponsor ID
- 1101710
- Conditions
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain Syndrome
- Keywords
- FGID, Neural Stimulation, Functional Abdominal Pain, Dysautonomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Posted 21 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the same electro auricular device
| Arm | Type | Receives |
|---|---|---|
| Percutaneous neurostimulation | Experimental | Device: Percutaneous neurostimulationSubjects will have 4 weeks of active therapy. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Mental retardation or pervasive developmental disorder or epilepsy
- Psychosis
- Genetic or chromosomal disorders
- Pregnancy
- Subjects who admit to substance abuse during screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous neurostimulationAlso: NSS-2 Bridge by Innovative Health SolutionsPercutaneous neurostimulation using NSS-2 Bridge device | Device | Percutaneous neurostimulation |
Primary outcome
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity
Time frame: 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.
2 secondary outcomes
To Measure Heart Rate Variability
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)
To Measure Functional Disability Inventory
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25378088He 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.
- Background: PubMed 28826627Kovacic 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.
- Background: PubMed 23927739Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisela Chelimsky, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous neurostimulation in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity (time frame: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.