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Vagus Nerve Stimulator

Vagal Nerve Stimulation for Indigestion and Gastroparesis

Phase < 1
Recruiting
Led By Roberta Sclocco, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
an idiopathic etiology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes
Awards & highlights

Study Summary

This trial will investigate whether electrical stimulation of the vagus nerve in the ear can improve symptoms in patients with functional dyspepsia or gastroparesis.

Who is the study for?
This trial is for adults aged 18-65 with gastroparesis or functional dyspepsia, diagnosed by specific criteria and tests. Participants must have stable medical treatment for a month prior to and during the study, no history of gastric surgery, arrhythmias, seizures, drug abuse or BMI over 32. They can't be pregnant/nursing or planning pregnancy.Check my eligibility
What is being tested?
The trial studies auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach in patients with indigestion issues like gastroparesis and functional dyspepsia. It aims to understand how taVNS affects these conditions.See study design
What are the potential side effects?
Potential side effects of taVNS may include discomfort at the stimulation site, headache, lightheadedness or fainting. Since it's non-invasive, serious side effects are less common but could involve changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Functional Dyspepsia as per Rome III criteria.
Select...
My condition has no known cause.
Select...
I have been diagnosed with Functional Dyspepsia as per Rome III criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neuroimaging
Secondary outcome measures
Electrocardiography (ECG)
Electrogastrography (EGG)
Respiration
+1 more
Other outcome measures
Brief Pain Inventory (BPI)
Liquid meal challenge
Short Form Nepean Dyspepsia Index (SF-NDI)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: taVNSExperimental Treatment1 Intervention
Active or inactive taVNS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2011
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,432 Total Patients Enrolled
7 Trials studying Gastroparesis
1,150 Patients Enrolled for Gastroparesis
Roberta Sclocco, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
Vitaly Napadow, PhDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
4 Previous Clinical Trials
198 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this investigation?

"To qualify for participation, candidates must have been diagnosed with gastroparesis and be between the ages of 18 to 65. This medical trial is hoping to enrol approximately 50 patients."

Answered by AI

Are there any opportunities to partake in this research initiative at the present time?

"Affirmative, according to the information hosted on clinicaltrials.gov this trial is actively recruiting participants. The investigation was first posted November 30th of 2018 and has been recently refreshed April 8th 2022. To meet their goals, 50 patients must be enrolled at a single site."

Answered by AI

How many individuals will be admitted to the research project?

"Yes, according to clinicaltrials.gov the trial is currently recruiting patients. The original post date was November 30th 2018 and the most recent update was April 8th 2022. 50 participants are required from a single medical centre for this study."

Answered by AI

Are individuals aged 35 and older eligible for participation in this investigation?

"The age parameters for this clinical trial are 18 and 65, respectively. Therefore, all participants must meet the aforementioned requirements in order to be enrolled."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Illinois
Massachusetts
How old are they?
65+
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
Braden Kuo 2018. "Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03603730.
All > Diabetic Gastroparesis > Dyspepsia
~9 spots leftby Mar 2025
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