Status:
RECRUITING
The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive Performance
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Aging
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 indi...
Detailed 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 resonanc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04908358
Start Date
November 24 2021
End Date
April 30 2026
Last Update
February 20 2025
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129