RECRUITING

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

Conditions

Aging Transcutaneous vagus nerve stimulation Memory Brainstem Preclinical Alzheimer's disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-24

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04908358

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Heidi IL Jacobs, PhD

CONTACT

6179097679

hjacobs@mgh.harvard.edu

Nina Engels, MSc

CONTACT

617-724-5354

nengels@mgh.harvard.edu

Principal Investigator

Heidi IL Jacobs, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Heidi IL Jacobs, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-24

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2021-11-24

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Transcutaneous vagus nerve stimulation
Memory
Brainstem
Aging
Preclinical Alzheimer's disease

Additional Relevant MeSH Terms

Aging