Non-invasive Nerve Stimulation and Cognitive Training to... | NCT04276805

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

NCT04276805

Sponsor

University of Florida

Status

Active, not recruiting

Last Update Posted

May 1, 2025Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Aging

Interventions

Transcutaneous vagal nerve stimulation (tVNS)
cognitive training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2020Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Oct 30, 2025Estimated

First Submitted Date

Feb 17, 2020

First Submission Date that Met QC Criteria

Feb 17, 2020

First Posted Date

Feb 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

May 1, 2025Actual

Name	Class
University of Arizona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tVNS group	Active Comparator	Participants will undergo cognitive training with tVNS	Device: Transcutaneous vagal nerve stimulation (tVNS) Behavioral: cognitive training
Sham group	Sham Comparator	Participants will undergo cognitive training with earlobe sham	Behavioral: cognitive training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous vagal nerve stimulation (tVNS)	Device	a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.	tVNS group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Williamson, PhD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85721	United States
University of Florida

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Apr 6, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 6, 2026			Apr 24, 2026	8
Jun 29, 2026

Intervention Browse Module

MeSH Terms

ID	Term
D000091942	Cognitive Training

Ancestor Terms

ID	Term
D000066530	Neurological Rehabilitation
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided