Non-invasive brain stimulation to improve cognition in older adults
The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive
NA · Massachusetts General Hospital · NCT04908358
This study is testing if a new type of brain stimulation can help older adults think better and improve their memory.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT04908358 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a non-invasive electrical brain stimulation method called RAVANS (transcutaneous vagus nerve stimulation) on cognitive performance in older individuals. It involves a randomized cross-over design where participants receive either active or sham stimulation during fMRI tasks. Following this, participants will undergo daily stimulation sessions over two weeks, with cognitive assessments conducted two months post-intervention. The study also aims to explore the relationship between cognitive outcomes and Alzheimer's disease biomarkers.
Who should consider this trial
Good fit: Ideal candidates are English-speaking older adults aged 60-85 with well-controlled vascular risk factors and no prior diagnosis of mild cognitive impairment or dementia.
Not a fit: Patients with a prior diagnosis of mild cognitive impairment or dementia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function in older adults, potentially delaying the onset of cognitive decline associated with aging.
How similar studies have performed: Other studies have shown promise with similar non-invasive brain stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlestown, Massachusetts
- Massachusetts General Hospital — Charlestown, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Heidi IL Jacobs, PhD — Massachusetts General Hospital
- Study coordinator: Heidi IL Jacobs, PhD
- Email: hjacobs@mgh.harvard.edu
- Phone: 6179097679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aging, Transcutaneous vagus nerve stimulation, Memory, Brainstem, Preclinical Alzheimer's disease