Acute Effects of Estradiol Administration on Brain Function During Fear Learning

Early Phase 1Not Yet RecruitingNCT07737613

University of Arizona30 enrolled

Overview

The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety symptoms and PTSD risk later in life.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

PTSD and Trauma-related Symptoms Cognitive Decline in Older Adults Post Menopausal Women

Interventions

estradiolDRUG

oral 2mg tablet of estradiol

Eligibility

Sex: FEMALEMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * post-menopausal * normal or corrected-to-normal vision * English speaking * stable medication use (no changes in the past three months) Exclusion Criteria: * use of hormone therapy containing synthetic estrogen * MRI contraindications (e.g., irremovable ferrous metal in body, claustrophobia) * history of neurological disorder (including mild cognitive impairment) or moderate to severe traumatic brain injury * use of antipsychotic, opiate, or mood stabilizer (i.e., lithium) medication * history of blood clots/deep vein thrombosis, prior stroke or TIA, uncontrolled hypertension * history of migraine with aura * severe liver disease * history of breast, endometrial, or ovarian cancer * smoking \>10 cigarettes/day

Outcomes

Primary Outcomes

Neural Response to Fear Conditioning Task

Estrogen has been shown to modulate the function of brain regions involved in fear processing, including the amygdala, hippocampus, and ventromedial prefrontal cortex. During fMRI, participants will complete a fear conditioning and generalization task to measure brain activity. They will view different neutral images of geometric shapes which may or may not predict the imminent receipt of an electric shock to the ankle. Across voxels of the brain, activation estimates (BOLD response) will be extracted for CS+ (conditioned threat) vs. CS- (conditioned safety) cues, and linear activation patterns across ambiguous generalization stimuli (i.e., GSs; CS+ \> GS1 \> GS2 \> GS3 \> CS-).

Time frame: single visit, approximately 4 hours after taking study drug

Secondary Outcomes

Skin Conductance Response

Sweat glands activate under stress, increasing the electrical conductance of the skin. Participants will have electrodes attached on their palm to measure changes in sympathetic nervous system activity, providing an objective, physiological measure of anticipatory anxiety.

Time frame: single visit, approximately 4 hours after taking study drug

Subjective Fear and Risk Ratings

Self-report can be used to ascertain subjective fear and explicit knowledge of threat contingencies. Participants will be asked to rate of perceived risk of each displayed stimulus from 1 (no risk) to 3 (high risk), contingency learning, and aversiveness of the stimulation (1-5) during task completion in the scanner and after.

Time frame: single visit, approximately 4 hours after taking study drug

Central Contacts

Nancy Huynh

CONTACT

520-333-5482 nxhuynh@arizona.edu

Data from ClinicalTrials.gov

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