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.
Eligible Conditions
- Gastroparesis
- Indigestion
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 40 minutes
2 hours
Electrocardiography (ECG)
Electrogastrography (EGG)
Neuroimaging
Respiration
Skin Conductance Levels (SCL)
40 minutes
Liquid meal challenge
5 minutes
Brief Pain Inventory (BPI)
Short Form Nepean Dyspepsia Index (SF-NDI)
Visual Analog Scale (VAS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
taVNS
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: taVNS · No Placebo Group · Phase < 1
taVNS
Device
Experimental Group · 1 Intervention: taVNS · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2021
N/A
~190
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 40 minutes
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,158 Total Patients Enrolled
5 Trials studying Gastroparesis
672 Patients Enrolled for Gastroparesis
Vitaly Napadow, PhDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
2 Previous Clinical Trials
78 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People between the ages of 18 and 65 who are willing to volunteer are welcome.
Based on the Rome III criteria, patients with functional dyspepsia are classified as either suffering frompostsphincteric dyspepsia (PDS) or epigastric pain syndrome (EPS).
The person has had symptoms of gastroparesis for at least 12 weeks, which may include nausea, vomiting, early satiety, and/or post-prandial fullness.
An idiopathic etiology is a cause of a disease or condition that is unknown or mysterious.
Do not drink alcohol, smoke cigarettes, or drink coffee for 24 hours before your study session.
The person has had abnormal gastric emptying scintigraphy results using a 4 hour low fat Egg Beaters protocol within the last 6 months
The subject was maintained on stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period.
Who else is applying?
What state do they live in?
| Massachusetts | 75.0% |
| Colorado | 25.0% |
How old are they?
| 65+ | 25.0% |
| 18 - 65 | 75.0% |
What site did they apply to?
| Massachusetts General Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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