Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
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|ClinicalTrials.gov Identifier: NCT03603730|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Gastroparesis||Device: taVNS||Early Phase 1|
The primary aims of this study are to 1) investigate the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain-gut signaling using a liquid meal test in functional dyspepsia (FD) and gastroparesis (GP) patients using combined gastric, autonomic and neuroimaging measures, and 2) evaluate the effectiveness of taVNS on FD and GP symptoms.
A total of 25 FD and 25 GP patients will be enrolled in this study, both females and males, ranging between 18 and 65 years of age. There will be multiple study visits consisting of a screening, baseline testing, consumption of a liquid meal, and fMRI brain and gut imaging sessions. Visits will include active and inactive taVNS delivered to the outer ear at a moderate, non-painful level.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||There will be multiple study visits consisting of a screening, baseline testing, consumption of a liquid meal, and fMRI brain and gut imaging sessions. Visits will include active and inactive taVNS delivered to the outer ear at a moderate, non-painful level.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||October 2020|
Active or inactive taVNS
Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.
- Neuroimaging [ Time Frame: 2 hours ]Functional magnetic resonance imaging (fMRI)
- Electrogastrography (EGG) [ Time Frame: 2 hours ]We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
- Electrocardiography (ECG) [ Time Frame: 2 hours ]We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex.
- Respiration [ Time Frame: 2 hours ]Respiration will be measured in beats per minute (bpm).
- Skin Conductance Levels (SCL) [ Time Frame: 2 hours ]SCL will measured in volts per second.
- Liquid meal challenge [ Time Frame: 40 minutes ]Patients will be studied in the morning after overnight fast. The liquid meal test will be conducted in the following way: subjects consume 120 ml of Ensure every 4 min until full. At 5 min intervals, participants score fullness using a rating scale that combines verbal descriptors on a scale graded 0-5. Participants are told to stop when a score of 5 is obtained.
- Short Form Nepean Dyspepsia Index (SF-NDI) [ Time Frame: 5 minutes ]Subjects will be asked to complete multiple questionnaires during the sessions, including the SF-NDI. The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study) as they pertain to the last week. Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
- Brief Pain Inventory (BPI) [ Time Frame: 5 minutes ]Subjects will be asked to complete multiple questionnaires during the sessions, including the BPI. The BPI assesses the severity of the subject's pain as well as the degree of disability and impact on daily functioning over the past 24 hours and past 7 days. This questionnaire includes a diagram of the human body in which the subject would shade in where they feel pain, placing an X on the area that hurts the most, as well as series of questions rating the subject's pain from 0 (no pain) to 10 (pain as bad as you can imagine) and on the relief felt from treatments or medications as measured from 0% (no relief) to 100% (complete relief).
- Visual Analog Scale (VAS) [ Time Frame: 5 minutes ]Subjects will be asked to complete multiple questionnaires during the sessions, including the VAS. The VAS measures satiation, abdominal pain/discomfort, nausea, bloating, and belching on a visual scale (0-100mm) with the descriptors "unnoticeable" and "unbearable" as anchors for 0mm and 100mm respectively. It will be administered at multiple time points across a session, with the sum of the 0-100mm scales for each symptom providing an aggregate symptom score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603730
|Contact: Rowan Staley, BAemail@example.com|
|Contact: April Mendez, BAfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Rowan Staley, BA 617-643-9790 email@example.com|
|Sub-Investigator: Brad Kuo, MD|
|Principal Investigator:||Vitaly Napadow, PhD||Massachusetts General Hospital|