COMPLETED

Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

Conditions

Acute Stress Reaction Cognitive Performance Healthy Human Performance Stress Vagus Nerve Stimulation Neurostimulation Transcutaneous Auricular Neurostimulation Military

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.

Official Title

Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

Quick Facts

Study Start:2024-11-26

Study Completion:2025-06-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06390267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 41 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults 18 to 41 years old 2. Participant has the cognitive and physical abilities to carry out the study tasks 3. Proficient in the English language 4. Ability to understand the explanations and instructions given by the study personnel	1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition 2. Participant has used any psychological stress-management intervention within the last 4 weeks 3. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial 4. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder 5. Participant is currently using anti-anxiety medications such as Xanax or beta blockers 6. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD. 7. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months 8. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation 9. Participant has a history of epileptic seizures 10. Participant has a history of neurologic diseases or traumatic brain injury 11. Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators) 12. Females who are pregnant or lactating 13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Inclusion Criteria

Exclusion Criteria

1. Adults 18 to 41 years old
2. Participant has the cognitive and physical abilities to carry out the study tasks
3. Proficient in the English language
4. Ability to understand the explanations and instructions given by the study personnel

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has used any psychological stress-management intervention within the last 4 weeks
3. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
4. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
5. Participant is currently using anti-anxiety medications such as Xanax or beta blockers
6. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
7. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
8. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation
9. Participant has a history of epileptic seizures
10. Participant has a history of neurologic diseases or traumatic brain injury
11. Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators)
12. Females who are pregnant or lactating
13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Contacts and Locations

Principal Investigator

Philip Putnam, PhD

PRINCIPAL_INVESTIGATOR

Battelle Memorial Institute

Navid Khodaparast, PhD

PRINCIPAL_INVESTIGATOR

Spark Biomedical, Inc.

Study Locations (Sites)

Battelle Memorial Institute

Columbus, Ohio, 43201

United States

Collaborators and Investigators

Sponsor: Spark Biomedical, Inc.

Philip Putnam, PhD, PRINCIPAL_INVESTIGATOR, Battelle Memorial Institute
Navid Khodaparast, PhD, PRINCIPAL_INVESTIGATOR, Spark Biomedical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26

Study Completion Date2025-06-18

Study Record Updates

Study Start Date2024-11-26

Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

Healthy Human
Performance
Stress
Vagus Nerve Stimulation
Neurostimulation
Transcutaneous Auricular Neurostimulation
Military

Additional Relevant MeSH Terms

Acute Stress Reaction
Cognitive Performance