Vagus Nerve Stimulation for Alzheimer's Disease
(WALLe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
In this research study the investigators want to find out if a non-invasive electrical brain stimulation method called RAVANS (also called tVNS) can have a beneficial effect on cognition in older individuals. The investigators also want to understand whether certain individual factors contribute to the effect of RAVANS on cognition. RAVANS is only used in research studies.
Will I have to stop taking my current medications?
The trial requires that your medications be stable for at least 30 days before participating, so you may need to continue your current medications without changes.
Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?
How does the treatment of transcutaneous vagus nerve stimulation for Alzheimer's disease differ from other treatments?
This treatment is unique because it uses non-invasive electrical stimulation of the ear to activate the vagus nerve, which may enhance cognitive function without the need for surgery or medication. Unlike traditional treatments, it offers a novel approach by potentially improving brain function through the modulation of neural pathways and cardiovascular stability.678910
What data supports the effectiveness of the treatment Vagus Nerve Stimulation for Alzheimer's Disease?
Transcutaneous vagus nerve stimulation (tVNS) has been shown to modulate brain activity and has been used successfully for conditions like epilepsy and depression, suggesting potential benefits for Alzheimer's Disease. It is a non-invasive method that stimulates the vagus nerve through the skin, which may help in managing symptoms by affecting brain function.45111213
Who Is on the Research Team?
Heidi IL Jacobs, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for individuals aged 60-85 with mild Alzheimer's or aging-related cognitive decline, fluent in English, and have stable health conditions like controlled hypertension. They must score within certain limits on cognitive tests and be right-handed. Exclusions include metal implants incompatible with MRI, severe psychiatric disorders, active cancer or heart disease, major head trauma history, substance abuse within the past two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cross-over Intervention
Participants undergo a cross-over design of sham versus RAVANS stimulation during a functional magnetic resonance imaging (fMRI) task
Treatment
Participants receive daily tVNS or sham sessions during 10 visits
Follow-up
Participants undergo two follow-up cognitive assessments to monitor changes in cognition and inflammatory responses
What Are the Treatments Tested in This Trial?
Interventions
- Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
- Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institute on Aging (NIA)
Collaborator