RECRUITING

Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Conditions

Dyspepsia Gastroparesis Functional Dyspepsia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.

Official Title

Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

Quick Facts

Study Start:2018-11-30

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03603730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Volunteers, female and male, between 18 and 65 years of age. 2. For healthy volunteers, ability to undergo MRI for up to 2 hours. 3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes. 4. For Gastroparesis patients, diagnosis will include the following criteria: * symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness * an idiopathic etiology * abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours.	1. History gastric/esophageal surgery 2. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period. 3. Illicit drugs or opioid use. 4. History of arrhythmias. 5. Implanted pacemaker. 6. Epilepsy or a prior history of seizures. 7. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs). 8. Pregnancy or nursing or plans to become pregnant. 9. Inability to provide informed consent. 10. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table). 11. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease may not be eligible to participate in the study and will require additional screening: * History of Head Trauma * Any metallic implants (e.g. braces or permanent retainers) * Tattoos with metallic ink above the nipple line * Surgical Aneurysm Clips * Cardiac Pacemaker * Prosthetic Heart Valve * Neurostimulator * Implanted pumps * Cochlear Implants * Metal rods, Plates, Screws * Recent Previous Surgery * IUD * Hearing Aid * Dentures (which might create NMR artifacts) * Metal Injury to eyes * Pregnancy or plans to become pregnant * Breast Feeding * Meniere's Disease * Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control) * Claustrophobia

Inclusion Criteria

Exclusion Criteria

1. Volunteers, female and male, between 18 and 65 years of age.
2. For healthy volunteers, ability to undergo MRI for up to 2 hours.
3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
4. For Gastroparesis patients, diagnosis will include the following criteria:
* symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
* an idiopathic etiology
* abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours.

1. History gastric/esophageal surgery
2. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
3. Illicit drugs or opioid use.
4. History of arrhythmias.
5. Implanted pacemaker.
6. Epilepsy or a prior history of seizures.
7. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
8. Pregnancy or nursing or plans to become pregnant.
9. Inability to provide informed consent.
10. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
11. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease may not be eligible to participate in the study and will require additional screening:
* History of Head Trauma
* Any metallic implants (e.g. braces or permanent retainers)
* Tattoos with metallic ink above the nipple line
* Surgical Aneurysm Clips
* Cardiac Pacemaker
* Prosthetic Heart Valve
* Neurostimulator
* Implanted pumps
* Cochlear Implants
* Metal rods, Plates, Screws
* Recent Previous Surgery
* IUD
* Hearing Aid
* Dentures (which might create NMR artifacts)
* Metal Injury to eyes
* Pregnancy or plans to become pregnant
* Breast Feeding
* Meniere's Disease
* Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
* Claustrophobia

Contacts and Locations

Study Contact

Andrew Bolender, BA

CONTACT

617-643-4297

abolender@mgh.harvard.edu

Principal Investigator

Roberta Sclocco, PhD

PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Roberta Sclocco, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-30

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2018-11-30

Study Completion Date2025-03-30

Terms related to this study

Keywords Provided by Researchers

Functional Dyspepsia
Gastroparesis

Additional Relevant MeSH Terms

Dyspepsia
Gastroparesis