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Vagus Nerve Stimulation for Alzheimer's Disease (WALLe Trial)

N/A
Recruiting
Led By Heidi IL Jacobs, 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
Aged 60-85, inclusive
Perform within 1.5 S.D. of age and education matched norms on the Logical Memory Paragraph Delayed Recall
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25
Awards & highlights

WALLe Trial Summary

This trial will test whether a non-invasive brain stimulation method can improve cognition in older adults, as well as whether certain individual factors contribute to the effect.

Who is the study for?
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.Check my eligibility
What is being tested?
The study examines if RAVANS (non-invasive electrical brain stimulation) can improve cognition in older adults. Participants will receive either the actual tVNS treatment or a sham (fake) version during ten-minute sessions to compare effects on brain function.See study design
What are the potential side effects?
Potential side effects of transcutaneous vagus nerve stimulation may include discomfort at the site of stimulation, headache, dizziness or fainting due to its effect on nerve activity. However, since it's non-painful and non-invasive, serious side effects are not common.

WALLe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 85 years old.
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My memory test scores are close to normal for my age and education level.

WALLe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Being a responder as determined by Face-name association memory task (FNAME) change scores
Performance on the Face-name association memory task (FNAME)
Secondary outcome measures
Change in inflammatory responses (C)
Change in inflammatory responses (MCP)
Change in inflammatory responses (MIP)
+5 more

WALLe Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: cross-over Stimulation-ShamExperimental Treatment2 Interventions
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by sham One time RAVANS versus one time Sham Two weeks wash-out
Group II: cross-over Sham-StimulationExperimental Treatment2 Interventions
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) One time RAVANS versus one time Sham Two weeks wash-out
Group III: Stimulation preceded by cross-over Stimulation-ShamExperimental Treatment1 Intervention
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by sham Wash-out period of four weeks Ten daily sessions of RAVANS during 2 weeks
Group IV: Stimulation preceded by cross-over Sham-StimulationExperimental Treatment1 Intervention
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Wash-out period of four weeks Ten daily sessions of RAVANS during 2 weeks
Group V: Sham preceded by cross-over Sham-StimulationPlacebo Group1 Intervention
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Wash-out period of four weeks Ten daily sessions of sham during 2 weeks
Group VI: Sham preceded by cross-over Stimulation-ShamPlacebo Group1 Intervention
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by Sham Wash-out period of four weeks Ten daily sessions of sham during 2 weeks

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,283 Total Patients Enrolled
11 Trials studying Aging
991 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,359 Total Patients Enrolled
160 Trials studying Aging
75,867 Patients Enrolled for Aging
Heidi IL Jacobs, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions Clinical Trial Eligibility Overview. Trial Name: NCT04908358 — N/A
Aging Research Study Groups: cross-over Sham-Stimulation, Stimulation preceded by cross-over Stimulation-Sham, Stimulation preceded by cross-over Sham-Stimulation, Sham preceded by cross-over Sham-Stimulation, Sham preceded by cross-over Stimulation-Sham, cross-over Stimulation-Sham
Aging Clinical Trial 2023: Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions Highlights & Side Effects. Trial Name: NCT04908358 — N/A
Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908358 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key goals of this medical study?

"The primary ambition of this scientific endeavour, which is to be assessed over a four week period (cross-over), revolves around the Face-name association memory task. Secondary objectives include evaluating fluctuations in inflammatory responses such as interleukins IL-1β, IL-2, IL-6 and IL-8; tumor necrosis factor alpha (TNFα); macrophage inflammatory protein 1b (MIP1B); monocyte chemoattractant protein 1(MCP1); C1q and C3 complement components. After stability analysis has been conducted with advice from Dr Arnold, specific markers will be selected for"

Answered by AI

Is participation in this study limited to individuals under forty years of age?

"This research study invites individuals aged between 60 and 85 years old to take part in it."

Answered by AI

Are there still opportunities to join this experiment?

"As indicated on clinicaltrials.gov, enrollment for this medical study is currently open. The trial was initially launched 24th November 2021 and underwent its last update 25th January 2022."

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Who is capable of participating in this clinical research?

"This clinical trial is currently inviting applicants aged 60 to 85. The aim is for 140 individuals to join the study."

Answered by AI

How many participants is this clinical trial hoping to recruit?

"Affirmative, according to the records on clinicaltrials.gov this medical trial is actively recruiting for participants. This research was first made available November 24th 2021 and has been recently updated January 25th 2022; requiring a total of 140 individuals from 1 locations."

Answered by AI
~63 spots leftby Feb 2026