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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
Sponsor:
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Dyspepsia Gastroparesis Device: taVNS Early Phase 1

Detailed Description:

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: taVNS
Active or inactive taVNS
Device: taVNS
Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.




Primary Outcome Measures :
  1. Neuroimaging [ Time Frame: 2 hours ]
    Functional magnetic resonance imaging (fMRI)


Secondary Outcome Measures :
  1. Electrogastrography (EGG) [ Time Frame: 2 hours ]
    We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.

  2. 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.

  3. Respiration [ Time Frame: 2 hours ]
    Respiration will be measured in beats per minute (bpm).

  4. Skin Conductance Levels (SCL) [ Time Frame: 2 hours ]
    SCL will measured in volts per second.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Volunteers, female and male, between 18 and 65 years of age.
  2. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
  3. 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 will not be eligible to participate in the study:

    • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Rowan Staley, BA 617-643-9790 rstaley@mgh.harvard.edu
Contact: April Mendez, BA 617-726-0196 amendez5@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rowan Staley, BA    617-643-9790    rstaley@mgh.harvard.edu   
Sub-Investigator: Brad Kuo, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Vitaly Napadow, PhD Massachusetts General Hospital

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Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03603730     History of Changes
Other Study ID Numbers: 2010P000440
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital:
Functional Dyspepsia
Gastroparesis
Additional relevant MeSH terms:
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Gastroparesis
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations