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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

Must not have

Active hematological, renal, pulmonary, endocrine or hepatic disorders

Active cardiovascular disease, stroke, congestive or severe heart failure

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

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active blood, kidney, lung, hormone, or liver disorder.

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I have a serious heart condition or have had a stroke.

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I have been diagnosed with mild cognitive impairment or dementia.

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I have had surgery to cut the nerves to my stomach.

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I have had a severe head injury that made me unconscious or needed hospital care.

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I have low blood pressure because of a nerve system issue.

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I frequently faint due to sudden drops in my heart rate and blood pressure.

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I have an active cancer, brain dysfunction due to a metabolic issue, or an infection.

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I have a serious heart valve problem.

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I do not have major psychiatric disorders or have not had ECT, but mild depression treated with SSRIs is okay.

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I have Huntington's disease, hydrocephalus, or a seizure disorder.

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I have been diagnosed with sick sinus syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Being a responder as determined by Face-name association memory task (FNAME) change scores

Performance on the Face-name association memory task (FNAME)

Secondary study objectives

Change in inflammatory responses (C)

Change in inflammatory responses (MCP)

Change in inflammatory responses (MIP)

+5 more

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

0 / 14Eligibility criteria met