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

NCT04276805 | Completed Results FDA Device

• 1 other identifier: IRB201902991
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Decline in brain health and associated loss of cognitive function in healthy aging decreases quality of life.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).

Conditions

Aging

Outcome Measures

Primary Outcomes (5)

• Hopkins Verbal Learning Test (Total Immediate Recall)

  The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. The total immediate recall score is the sum of correct words recalled after each of the 3 learning trials, which can range from 0 to 36.

  At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).

• Hopkins Verbal Learning Test (Total Delayed Recall)

  The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 12) after a 20-25 minute delay.

  At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).

• Hopkins Verbal Learning Test (Total Retention)

  The Hopkins Verbal Learning Test-Revised (HVLT-R) is a verbal learning and memory measure involving learning a 12-item word list across three learning trials followed by delayed recall after approximately 20-25 minutes. The Total Retention score is calculated by dividing the delayed recall score (range: 0-12) by the higher score from Learning Trial 2 or Learning Trial 3 (range: 0-12) and multiplying by 100 to yield the percentage of words retained following the delay period. Higher percentage scores indicate better retention of learned information. A score of 100% indicates that delayed recall performance was equal to the participant's best learning trial. Percentage scores greater than 100% are possible when delayed recall performance exceeds the participant's highest score on Learning Trial 2 or Learning Trial 3.

  At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).

• Hopkins Verbal Learning Test (Recognition)

  The Hopkins Verbal Learning Test (HVLT-R) is a verbal learning and memory task with a 12-item word list learned over 3 trials. Within the delayed yes-no recognition part of the task, the participant is presented with a larger list or words and responds to whether each was on the original 12-item list. The recognition discrimination index score is calculated as number of hits (correctly identified words from the list) - number of false positive words (incorrectly identified words that were not on the list), with scores ranging from 0 to 12 (perfect score).

  At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).

• NIH Toolbox Fluid Cognitive Composite

  The National Institutes of Health (NIH) Toolbox Fluid Cognition Composite is a standardized measure of fluid cognitive functioning derived from performance on five tests assessing attention, executive function, working memory, episodic memory, and processing speed (Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory, List Sorting Working Memory, and Pattern Comparison). Scores are reported as Fully Corrected T-scores derived from NIH Toolbox normative data and adjusted for demographic characteristics including age, sex, race/ethnicity, and education. Fully Corrected T-scores have a normative mean of 50 and standard deviation of 10. Higher T-scores indicate better fluid cognitive functioning, whereas lower T-scores indicate poorer fluid cognitive functioning. A T-score of 50 represents average performance relative to the normative population.

  At baseline (intake assessment) and at the post-intervention assessment conducted following completion of the 2-week cognitive training intervention (approximately 2 to 3 weeks after baseline, depending on scheduling).

Study Arms (2)

tVNS group

ACTIVE COMPARATOR

Participants will be randomly assigned to receive either active tVNS or sham stimulation during two weeks of cognitive training and will complete assessments before and after completion of this intervention. Participants in the tVNS group will undergo cognitive training paired with tVNS.

Device: Transcutaneous vagal nerve stimulation (tVNS); Behavioral: Cognitive training

Sham group

SHAM COMPARATOR

Participants will be randomly assigned to receive either active tVNS or sham stimulation during two weeks of cognitive training and will complete assessments before and after completion of this intervention. Participants in the tVNS group will undergo cognitive training paired with sham stimulation.

Behavioral: Cognitive training

Interventions

Transcutaneous vagal nerve stimulation (tVNS) DEVICE

The active tVNS group will receive non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 2x sensory threshold (25Hz, 200 μs pulse width) using electrodes placed at the left tragus. The sham group will receive sham stimulation (0x sensory threshold) using electrodes placed on the left earlobe.

tVNS group

Cognitive training BEHAVIORAL

Cognitive training will be delivered for one hour daily over a two-week period via a web-based program (Posit Science BrainHQ, accessed through www.positscience.com) containing eight adaptive tasks targeting attention, processing speed, and working memory. Participants will complete four randomly selected tasks per hour of training.

Sham group; tVNS group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead
• University of Arizona: collaborator

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: John Williamson, PhD, ABPP-CN
• Organization: University of Florida

john.williamson@ufl.edu

352-548-6920

Study Officials

• John Williamson, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: July 27, 2026
• Results First Posted: July 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)