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Neurostimulation Device
Vagus Nerve Stimulation for Alzheimer's Disease
Phase < 1
Recruiting
Led By Vitaly Napadow, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how well vagus nerve stimulation works in people with Alzheimer's disease.
Who is the study for?
This trial is for right-handed, healthy individuals without any neurological or psychiatric disorders, pain syndromes, or conditions that would make an fMRI brain scan unsafe.
What is being tested?
The study tests how active Transcutaneous Electrical Acupoint Stimulation (TEAS) affects the brain, stomach function, and autonomic nervous system activity in healthy subjects.
What are the potential side effects?
While TEAS is generally considered safe for most people, potential side effects may include mild skin irritation at the stimulation site and discomfort from the electrical current.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain activity during functional magnetic resonance imaging (fMRI)
Stomach activity during gastric magnetic resonance imaging (MRI)
Secondary study objectives
Electrocardiography (ECG)
Electrogastrography (EGG)
Respiration
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: IncongruentExperimental Treatment1 Intervention
Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.
Group II: CongruentExperimental Treatment1 Intervention
Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,739 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,183 Total Patients Enrolled
Vitaly Napadow, PhDPrincipal Investigator - Harvard University
Massachusetts General Hospital
4 Previous Clinical Trials
203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be right-handed.You have any problems related to your brain or mental health.You have any type of pain condition.You have a medical condition that prevents you from undergoing an fMRI brain scan.
Research Study Groups:
This trial has the following groups:- Group 1: Congruent
- Group 2: Incongruent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT00200889 — Phase < 1