The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive Performance (WALLe)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    140
  • sponsor
    Massachusetts General Hospital
Updated on 22 March 2022
Accepts healthy volunteers

Summary

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.

Description

The intervention will be studied in 140 older individuals using a randomized cross-over design of sham versus RAVANS stimulation (2 sessions separated by 4 weeks) during a functional magnetic resonance imaging (fMRI) task. Participants will then be randomized to daily tVNS or sham sessions during 10 visits within two weeks, and two follow-up cognitive assessments each after 2 months of the last intervention session. The face-name association task will be the main outcome measure. The investigators will also draw blood twice to examine whether the response on the outcome is dependent on Alzheimer's disease related biomarker, and whether RAVANS has effects on inflammatory responses.

Details
Condition Aging
Treatment 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
Clinical Study IdentifierNCT04908358
SponsorMassachusetts General Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Fluent in English
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

Prior known diagnosis of mild cognitive impairment (MCI) or dementia
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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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