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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: t
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• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Charlestown
Contact Information
Primary
Heidi IL Jacobs, PhD
hjacobs@mgh.harvard.edu
6179097679
Backup
Nina Engels, PhD
nengels@mgh.harvard.edu
617-724-5354
Time Frame
Start Date: 2021-11-24
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 140
Treatments
Sham_comparator: Sham preceded by cross-over Sham-Stimulation
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Wash-out period of four weeks Ten daily sessions of sham during 2 weeks
Sham_comparator: Sham preceded by cross-over Stimulation-Sham
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by Sham Wash-out period of four weeks Ten daily sessions of sham during 2 weeks
Experimental: Stimulation preceded by cross-over Sham-Stimulation
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Wash-out period of four weeks Ten daily sessions of RAVANS during 2 weeks
Experimental: Stimulation preceded by cross-over Stimulation-Sham
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by sham Wash-out period of four weeks Ten daily sessions of RAVANS during 2 weeks
Other: cross-over Stimulation-Sham
Cross-over: experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) followed by sham One time RAVANS versus one time Sham Two weeks wash-out
Other: cross-over Sham-Stimulation
Cross-over: Sham followed by experimental Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) One time RAVANS versus one time Sham Two weeks wash-out
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov