The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive Performance
NCT ID: NCT04908358
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2021-11-24
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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Sham preceded by cross-over Sham-Stimulation
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
Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Sham stimulation of vagus nerve in the outer ear
Sham preceded by cross-over Stimulation-Sham
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
Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Sham stimulation of vagus nerve in the outer ear
Stimulation preceded by cross-over Sham-Stimulation
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
Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Stimulation of vagus nerve in the outer ear
Stimulation preceded by cross-over Stimulation-Sham
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
Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Stimulation of vagus nerve in the outer ear
cross-over Stimulation-Sham
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
Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Stimulation of vagus nerve in the outer ear
Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Sham stimulation of vagus nerve in the outer ear
cross-over Sham-Stimulation
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
Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Stimulation of vagus nerve in the outer ear
Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Sham stimulation of vagus nerve in the outer ear
Interventions
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Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Stimulation of vagus nerve in the outer ear
Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions
Sham stimulation of vagus nerve in the outer ear
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to comply with scheduled visits, magnetic resonance imaging (MRI) scanning, laboratory tests, and other study procedures.
* Subjects with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well controlled Type II diabetes will be included.
* Stable medications for at least 30 days.
* Mini Mental State Exam adjusted for age and education of 25 to 30, inclusive or a Telephone Interview for Cognitive Status score of at least 32
* Perform within 1.5 S.D. of age and education matched norms on the Logical Memory Paragraph Delayed Recall
* Geriatric Depression Scale \< 11
* Aged 60-85, inclusive
* Right-handed
* Reduced vision is allowed if it can be corrected with MRI-goggles
Exclusion Criteria
* Use of investigational drugs or devices within 60 days prior to screening
* Subjects with contraindications to MRI cannot participate (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia)
* Pregnant.
* Major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with electroconvulsive therapy (ECT) (Mild depression that is well treated with stable dose of selective serotonergic reuptake inhibitor (SSRI) antidepressants will be allowed).
* Have a history of major head trauma defined as a loss of consciousness and/or trauma requiring hospitalization
* Substance abuse within the past 2 years
* Active hematological, renal, pulmonary, endocrine or hepatic disorders.
* Evidence of cortical infarcts or strategically placed lacunar infarct (e.g. dorsal medial nucleus of thalamus). MRI evidence of mild white matter signal abnormalities will be allowed.
* Active cancer, metabolic encephalopathy, infection
* Active cardiovascular disease, stroke, congestive or severe heart failure
* Huntington's disease, hydrocephalus or seizure disorder
* Cataracts, glaucoma, detached retina's, eye surgery involving the muscles; droopy eyelids, penetrating eye wounds and use of anticholinergic eye drop use
* Weight equal to or greater than 300 lbs (weight limit of the MRI table).
* Recurrent vaso-vagal syncopal episodes
* Unilateral or bilateral vagotomy
* Severe valvular disorder (i.e. prosthetic valve or hemodynamically relevant valvular diseases)
* Sick sinus syndrome
* Hypotension due to autonomic dysfunction
60 Years
85 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Heidi Jacobs
Associate Professor of Radiology
Principal Investigators
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Heidi IL Jacobs, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Charlestown, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Heidi IL Jacobs, PhD
Role: primary
Other Identifiers
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2021P000498
Identifier Type: -
Identifier Source: org_study_id
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