Influence of Stress on Encoding and Prediction

Stress Clinical Trial

Official title:

Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920161
• Other study ID #: 2000030825
• Secondary ID: 1R21MH128740-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Elizabeth V Goldfarb, PhD
• Phone: 203-737-6365
• Email: elizabeth.goldfarb[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.

Description:

This study aims to assess the neural and behavioral mechanisms by which acute stress modulates episodic encoding (which involves the trisynaptic pathway: entorhinal cortex, dentate gyrus, cornu ammonis [CA] 3, and CA 1) and statistical learning (monosynaptic pathway: entorhinal cortex, CA1) in humans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 years old

• Fluent in English

• BMI 18-35

Exclusion Criteria:

• Meeting current DSM-V criteria for any substance use disorder (except caffeine)

• Having current significant medical conditions or psychiatric symptoms requiring medication

• Current use of medications/drugs that interfere with physiological stress responses

• Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies

• Metal in body (for MRI safety) history will be assessed for female participants.

Related Conditions & MeSH terms

• Learning, Spatial
• Stress

Intervention

Behavioral:
• Socially Evaluated Cold Pressor Test
The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements
• Control
This is matched to the SECPT but with warm instead of cold water

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fMRI signal	fMRI signal during learning will be assessed using connectivity, multivariate, and univariate approaches over 1-2 hour long learning period	1-2 hours
Primary	Statistical learning	Online measures of statistical learning (reaction time) based on item predictability during task	1-2 hours
Primary	Retention of statistical learning	Offline measure of statistical learning assessed through familiarity tests the next day (comparison of accurate recognition of previously-studied pairs to chance, 50%)	1 hour
Primary	Episodic memory	Memory for individual items will be assessed through performance on old/new recognition tests the next day, quantified as hit rates and A' (non-parametric normalized ratio of hits to false alarms)	1 hour
Secondary	Cortisol reactivity	Change in salivary cortisol levels following the SECPT/control procedure	1-2 hours
Secondary	Alpha-amylase reactivity	Change in salivary alpha-amylase levels following the SECPT/control procedure	1-2 hours