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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Device: Transcutaneous vagal nerve stimulation (tVNS); Behavioral: cognitive training

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tVNS group; Participants will undergo cognitive training with tVNS	Device: Transcutaneous vagal nerve stimulation (tVNS); a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.; Behavioral: cognitive training; A program of regular mental activities purported to maintain or improve one's cognitive abilities.
Sham Comparator: Sham group; Participants will undergo cognitive training with earlobe sham	Behavioral: cognitive training; A program of regular mental activities purported to maintain or improve one's cognitive abilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in working memory and processing speed contributors	The Posit Science BrainHQ	Baseline to 2 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: University of Arizona
• Investigators: Principal Investigator: John Williamson, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB201902991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes