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Stress-induced Scratching in Healthy and AD

Primary Purpose

Healthy, Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trier Social Stress Test (TSST)
Landscape Video
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy subjects and AD patients between 18 and 59 years of age.
  2. Healthy subjects: In general, good health without history of neurological and psychiatric diseases.
  3. AD patients: An average itch rating of 3 out of 10 or greater in the past two weeks using a Numerical Rating Scale (NRS).
  4. 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).
  5. Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
  6. 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.
  7. Participants have to be able to speak and read English fluently.
  8. Participants must have signed a written informed consent before being enrolled in the study

Exclusion Criteria:

  1. Individuals under 18 or over 59 years of age.
  2. Inability to complete the required measures.
  3. Suffering from any disease state or physical condition, which would increase their health risk by study participation.
  4. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
  5. Recent initiation (within last 3 months) of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
  6. 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.
  7. Current treatment with opioid analgesics.
  8. Uncontrolled thyroid disease.
  9. Use of illicit drugs or history of opiate addiction.
  10. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active right now.
  11. 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).
  12. Inability to speak and read English.
  13. Being pregnant.
  14. Incarcerated.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants with AD with MRI

Healthy Participants with MRI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2019
Last Updated
August 9, 2022
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04174651
Brief Title
Stress-induced Scratching in Healthy and AD
Official Title
The Cerebral Mechanism of Stress-Induced Spontaneous Scratching in Healthy Volunteers and Patients With Atopic Dermatitis (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Atopic Dermatitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover randomization within the arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with AD with MRI
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Participants with MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test (TSST)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Landscape Video
Intervention Description
Participants randomized to receive the control condition will be watching a landscape video for 10 minutes.
Primary Outcome Measure Information:
Title
Changes in brain activity
Description
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).
Time Frame
Baseline, 15 minutes
Title
Change in time of spontaneous scratching
Description
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.
Time Frame
Baseline, 15 minutes
Secondary Outcome Measure Information:
Title
Correlation of perceived stress with stress-induced brain activity
Description
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).
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideki Mochizuki, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stress-induced Scratching in Healthy and AD

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