Stress-induced Scratching in Healthy and AD

NCT04174651 | Completed

• 1 other identifier: 20190833
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine scratching behavior and identify brain areas responsible for stress-induced spontaneous scratching in patients with atopic dermatitis (AD).

Conditions

Healthy; Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Changes in brain activity

  Changes in brain activity will be measured as change in Arterial spin Labeling (ASL) which reflects regional cerebral blood flow. This will be evaluated using functioning magnetic resonance imaging (fMRI).

  Baseline, 15 minutes

• Change in time of spontaneous scratching

  Change in spontaneous scratching for behavioral only arms will be calculated by subtracting total duration of scratching behavior before and after the TSST and Landscape video.

  Baseline, 15 minutes

Secondary Outcomes (1)

• Correlation of perceived stress with stress-induced brain activity

  60 minutes

Study Arms (2)

Participants with AD with MRI

EXPERIMENTAL

Participants that are diagnosed with AD will receive both the acute stress condition (TSST) and the control condition (watching a landscape video). The order when the 2 conditions will be provided is randomized per participant and completed 2 weeks apart. These subjects will be evaluated with MRI.

Behavioral: Trier Social Stress Test (TSST); Behavioral: Landscape Video

Healthy Participants with MRI

EXPERIMENTAL

Healthy participants will receive both the acute stress condition (TSST) and the control condition (watching a landscape video). The order when the 2 conditions will be provided is randomized per participant and completed 2 weeks apart. These subjects will be evaluated with MRI.

Behavioral: Trier Social Stress Test (TSST); Behavioral: Landscape Video

Interventions

Trier Social Stress Test (TSST) BEHAVIORAL

Participants randomized to receive the acute stress condition will undergo the TSST wherein the participant will be introduced to an upcoming task (i.e., job interview) and allowed to prepare (2 minutes). The participant will then be required to speak (job interview) for 4 minutes in front of 2 experimenters. After completion of the interview, participants will be asked to perform a mental arithmetic task for 4 minutes.

Healthy Participants with MRI; Participants with AD with MRI

Landscape Video BEHAVIORAL

Participants randomized to receive the control condition will be watching a landscape video for 10 minutes.

Healthy Participants with MRI; Participants with AD with MRI

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects and AD patients between 18 and 59 years of age.
• Healthy subjects: In general, good health without history of neurological and psychiatric diseases.
• AD patients: An average itch rating of 3 out of 10 or greater in the past two weeks using a Numerical Rating Scale (NRS).
• All patients will be required to cease use of oral antihistamines from the night before each study visit until the end of the experiment. The purpose is to avoid that participants fall asleep during MRI measurement due to side effect oral antihistamine (i.e., sedation).
• Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
• MRI Compatibility, criteria include having no major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
• Participants have to be able to speak and read English fluently.
• Participants must have signed a written informed consent before being enrolled in the study

You may not qualify if:

• Individuals under 18 or over 59 years of age.
• Inability to complete the required measures.
• Suffering from any disease state or physical condition, which would increase their health risk by study participation.
• Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
• Recent initiation (within last 3 months) of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
• Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity and perceived stress due to the stress task.
• Current treatment with opioid analgesics.
• Uncontrolled thyroid disease.
• Use of illicit drugs or history of opiate addiction.
• Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active right now.
• Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
• Inability to speak and read English.
• Being pregnant.
• Incarcerated.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Hideki Mochizuki, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Crossover randomization within the arms.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 22, 2019
• Study Start: January 27, 2020
• Primary Completion: April 28, 2021
• Study Completion: July 19, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)