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

Not Applicable

Active, not recruiting

• Conditions: Aging
• Interventions: Device: Transcutaneous vagal nerve stimulation (tVNS); Behavioral: cognitive training

• Registration Number: NCT04276805
• Lead Sponsor: University of Florida

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-11-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Healthy individuals willing to commit to study requirements

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tVNS group	cognitive training	Participants will undergo cognitive training with tVNS
Sham group	cognitive training	Participants will undergo cognitive training with earlobe sham
tVNS group	Transcutaneous vagal nerve stimulation (tVNS)	Participants will undergo cognitive training with tVNS

Primary Outcome Measures

Name	Time	Method
Change in working memory and processing speed contributors	Baseline to 2 weeks	The Posit Science BrainHQ

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States