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Completed

NCT Number: NCT04174651

Stress-induced Scratching in Healthy and AD

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).

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Landscape Video

Behavioral

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

Primary outcomes

  1. Changes in brain activity

    Time frame: Baseline, 15 minutes

    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).

  2. Change in time of spontaneous scratching

    Time frame: Baseline, 15 minutes

    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.

Secondary outcomes

  1. Correlation of perceived stress with stress-induced brain activity

    Time frame: 60 minutes

    The correlation of stress-induced brain activity evaluated as ASL signals will be evaluated against participant's stress questionnaire scores and biological stress marker (saliva cortisol levels).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

The Cerebral Mechanism of Stress-Induced Spontaneous Scratching in Healthy Volunteers and Patients With Atopic Dermatitis (AD)

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 22, 2019
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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