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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 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

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 more

Awards & 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
3,015 Previous Clinical Trials
13,309,310 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,709 Total Patients Enrolled
Vitaly Napadow, PhDPrincipal Investigator - Harvard University
Massachusetts General Hospital
4 Previous Clinical Trials
203 Total Patients Enrolled

Media Library

active auricular tVNS (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT00200889 — Phase < 1
Healthy Subjects Research Study Groups: Congruent, Incongruent
Healthy Subjects Clinical Trial 2023: active auricular tVNS Highlights & Side Effects. Trial Name: NCT00200889 — Phase < 1
active auricular tVNS (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00200889 — Phase < 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT00200889 — Phase < 1
~33 spots leftby Jun 2028
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