Stress-induced Scratching in Healthy and AD

Not Applicable

Completed

• Conditions: Healthy; Atopic Dermatitis
• Interventions: Behavioral: Trier Social Stress Test (TSST); Behavioral: Landscape Video

• Registration Number: NCT04174651
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2020-01-27
• Primary Completion: 2021-04-28
• Study Completion: 2022-07-19
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Participants with MRI	Trier Social Stress Test (TSST)	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.
Participants with AD with MRI	Landscape Video	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 with MRI	Landscape Video	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.
Participants with AD with MRI	Trier Social Stress Test (TSST)	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.

Primary Outcome Measures

Name	Time	Method
Changes in brain activity	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).
Change in time of spontaneous scratching	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 Outcome Measures

Name	Time	Method
Correlation of perceived stress with stress-induced brain activity	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).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States