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Behavioural Intervention

Vagal Nerve Stimulation for Gastroparesis (ABVN2 Trial)

N/A
Recruiting
Led By Thomas V Nowak, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-80 years
Healthy volunteers with no gastric symptoms or conditions (except due to COVID-19)
Must not have
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

Summary

"This trial involves studying the effects of vagal nerve stimulation on patients with a gastric electrical stimulation device and healthy volunteers. The study will measure the nerve action potentials and gastric hormone changes in response to auricular

Who is the study for?
This trial is for individuals with gastroparesis, a condition that affects stomach emptying. It's open to those who haven't had a gastric stimulator placed and are interested in non-invasive nerve stimulation therapy.
What is being tested?
The study tests the effects of ABVN (auricular branch of vagal nerve) stimulation on nerve action potentials and gastric hormones using devices like GES, TaVNS, PENFS, and a wrist-worn Cardio Watch.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, dizziness or changes in heart rate due to the electrical nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am healthy with no stomach issues unrelated to COVID-19.
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I have been diagnosed with gastroparesis by a GI doctor.
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I am between 18 and 80 years old.
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I have been diagnosed with gastroparesis or am seeing a doctor for gastroparesis symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess how various types of stimulation affect bodily systems and blood serum levels.
To assess participant autonomic responses to mild transcutaneous auricular vagus nerve stimulation (taVNS)
Secondary study objectives
To assess participant autonomic responses to taVNS stimulation.
To measure respiratory changes in heart rate during ABVN and also during the vagal maneuvers phase.
To measure the Heart rate variability (HRV), vagal nerve compound action potentials and in subjects undergoing VNS Therapy
+7 more
Other study objectives
The investigators would like to study the autonomic responses for EDS patients and matched controls using wearable watch device and transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Total of 40 gastroparetic patients will be enrolled with diabetic and idiopathic patients.Experimental Treatment1 Intervention
Investigators propose to study the effect on gastric hormone before, during and after auricular stimulation. The proposal is to enroll 30 healthy volunteers with no gastric symptoms to undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. This is based upon the results obtained in our previous IRB approved study where blood was drawn in patients who had gastric electrical stimulation device implanted. Blood was drawn to study the effects of stimulation on gastric hormones. (Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus nerve in Patients with Gastroparesis- IRB 1206008988)
Group II: The PENFS-percutaneous electrical field stimulation armExperimental Treatment2 Interventions
Using percutaneous electrical field stimulation (PENFS) on vagal nerve in healthy volunteers and study the effect on the compound actions, parasympathetic and sympathetic vagal nerve activity and gastric myoelectrical (EGG) activity. A total of 24 healthy volunteers will be enrolled in this pilot study.
Group III: Insulin, Glucose and C-peptide Blood Draw Group of Gastroparetic PatientsExperimental Treatment1 Intervention
This arm part is also to enroll 40 gastroparetic subjects to undergo blood draw before, after transcutaneous stimulation of the auricular branch of the vagus nerve, and a third draw after a period of no stimulation. Blood Draws are to obtain levels of Insulin, Glucose, and C-peptide for: baseline, Experimental and Recovery.
Group IV: GP subjects undergo vagal maneuver including food study with the bipolar EKGExperimental Treatment2 Interventions
This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation in Gastroparetic (GP)
Group V: EDS- Ehlers Danlos Syndrome ArmExperimental Treatment2 Interventions
The PI and the research team would like to recruit subjects that have both the diagnosis of gastroparesis and EDS or EDS only to further study the effect of the stimulation on the heart rate variability. A total of 60 subjects will be enrolled. The next phase of the study would like to study the autonomic responses for EDS patients and matched controls using wearable watch device and transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS).
Group VI: 25 subjects Healthy Subjects, but have undergone VNS TherapyExperimental Treatment2 Interventions
This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation (VNS) Therapy, for the treatment of partial or focal seizures will be recruited for the study.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,113,885 Total Patients Enrolled
10 Trials studying Gastroparesis
6,754 Patients Enrolled for Gastroparesis
Thomas V Nowak, MDPrincipal InvestigatorIndiana University
3 Previous Clinical Trials
72 Total Patients Enrolled
1 Trials studying Gastroparesis
40 Patients Enrolled for Gastroparesis
~163 spots leftby Dec 2028
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