Vagus Nerve Stimulation for Alzheimer's Disease
(WALLe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method called RAVANS (transcutaneous vagus nerve stimulation), which uses mild electrical stimulation on the ear, to determine if it can improve thinking skills in people with Alzheimer's disease. Researchers aim to understand how this treatment affects cognition and whether individual factors influence its effectiveness. Participants will receive either the actual RAVANS treatment or a sham (placebo) treatment in a crossover design. Suitable candidates for this trial include those who speak English, have managed health conditions like high blood pressure or diabetes, and maintain stable medication routines. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance Alzheimer's treatment options.
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.
What prior data suggests that this method is safe for use in older individuals?
Research has shown that transcutaneous vagus nerve stimulation (tVNS), such as RAVANS, is generally well-tolerated. Studies indicate that side effects are usually mild and temporary, including slight tingling or minor skin redness at the application site. The reviewed studies provide no strong evidence of serious safety concerns. This suggests that the treatment is generally safe, with minor side effects being the most commonly reported issues.12345
Why are researchers excited about this trial?
Researchers are excited about vagus nerve stimulation for Alzheimer's disease because it offers a novel approach that targets the brain's communication pathways. Unlike standard treatments like cholinesterase inhibitors and memantine, which work to manage symptoms, this technique uses non-painful electrical stimulation of the ear to potentially alter brain function and slow disease progression. The treatment is non-invasive and could be a game-changer by providing a new way to influence brain health without the side effects associated with many medications.
What evidence suggests that this method is effective for Alzheimer's Disease?
Research has shown that transcutaneous vagus nerve stimulation (tVNS) might help with memory problems related to Alzheimer's disease. This non-invasive method uses gentle electrical pulses and does not require surgery. In this trial, participants will receive either active tVNS or sham tVNS in a cross-over design. One study found that tVNS improved memory and slowed memory loss. Another study suggested that tVNS might enhance thinking skills in people with mild cognitive impairment (MCI), which can lead to Alzheimer's. These findings indicate that tVNS could be a promising new way to help older adults with memory challenges.16789
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