NCT03603730 Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
| NCT ID | NCT03603730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2018-11-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2018-11-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.
Eligibility Criteria
Inclusion 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. 4\) Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period. 5\) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session. Exclusion Criteria: 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
Contact & Investigator
Roberta Sclocco, PhD
PRINCIPAL INVESTIGATOR
Spaulding Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT03603730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03603730 currently recruiting?
Yes, NCT03603730 is actively recruiting participants. Contact the research team at abolender@mgh.harvard.edu for enrollment information.
Where is the NCT03603730 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03603730 clinical trial?
NCT03603730 is sponsored by Massachusetts General Hospital. The principal investigator is Roberta Sclocco, PhD at Spaulding Rehabilitation Hospital. The trial plans to enroll 65 participants.