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NCT04908358Completed

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

The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
126 (actual)
First submitted
4 May 2021
Start date
24 Nov 2021
Primary completion date
25 Aug 2026
Lead sponsor
Massachusetts General Hospital
NCT number
NCT04908358

What you commit to

  • Study type: Interventional
  • Participants enrolled: 126
  • From 24 Nov 2021 to the primary completion date, 25 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior known diagnosis of mild cognitive impairment (MCI) or dementia
  • Use of investigational drugs or devices within 60 days prior to screening
  • 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).
  • Cataracts, glaucoma, detached retina's, eye surgery involving the muscles; droopy eyelids, penetrating eye wounds and use of anticholinergic eye drop use

Other illness

  • 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)
  • Have a history of major head trauma defined as a loss of consciousness and/or trauma requiring hospitalization
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders.
  • Active cancer, metabolic encephalopathy, infection
  • Active cardiovascular disease, stroke, congestive or severe heart failure
  • Huntington's disease, hydrocephalus or seizure disorder
  • Severe valvular disorder (i.e. prosthetic valve or hemodynamically relevant valvular diseases)
  • Sick sinus syndrome

Other

  • Pregnant.
  • Substance abuse within the past 2 years
  • 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.
  • Weight equal to or greater than 300 lbs (weight limit of the MRI table).
  • Recurrent vaso-vagal syncopal episodes
  • Unilateral or bilateral vagotomy
  • Hypotension due to autonomic dysfunction

Who the study is looking for

  • 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

Age in the registry: 60 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
CharlestownUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.