Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
1 other identifier
interventional
7
1 country
2
Brief Summary
We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMay 1, 2025
April 1, 2025
5 years
February 17, 2020
April 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in working memory and processing speed contributors
The Posit Science BrainHQ
Baseline to 2 weeks
Study Arms (2)
tVNS group
ACTIVE COMPARATORParticipants will undergo cognitive training with tVNS
Sham group
SHAM COMPARATORParticipants will undergo cognitive training with earlobe sham
Interventions
a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.
A program of regular mental activities purported to maintain or improve one's cognitive abilities.
Eligibility Criteria
You may qualify if:
- Healthy individuals willing to commit to study requirements
You may not qualify if:
- Neurological disorders to include traumatic brain injury.
- Evidence of dementia .
- Major psychiatric illness
- Unstable and chronic medical conditions.
- MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
- Physical impairment precluding motor response or lying still or walking
- Hearing or vision deficits that will not allow for completion of assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- University of Arizonacollaborator
Study Sites (2)
University of Arizona
Tucson, Arizona, 85721, United States
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Williamson, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 19, 2020
Study Start
November 17, 2020
Primary Completion
October 30, 2025
Study Completion
October 30, 2025
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share