Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults

NCT ID: NCT04276805

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2025-10-30

Brief Summary

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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).

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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tVNS group

Participants will undergo cognitive training with tVNS

Group Type ACTIVE_COMPARATOR

Transcutaneous vagal nerve stimulation (tVNS)

Intervention Type DEVICE

a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.

cognitive training

Intervention Type BEHAVIORAL

A program of regular mental activities purported to maintain or improve one's cognitive abilities.

Sham group

Participants will undergo cognitive training with earlobe sham

Group Type SHAM_COMPARATOR

cognitive training

Intervention Type BEHAVIORAL

A program of regular mental activities purported to maintain or improve one's cognitive abilities.

Interventions

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Transcutaneous vagal nerve stimulation (tVNS)

a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.

Intervention Type DEVICE

cognitive training

A program of regular mental activities purported to maintain or improve one's cognitive abilities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals willing to commit to study requirements

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Williamson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201902991

Identifier Type: -

Identifier Source: org_study_id

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