Stress-induced Scratching in Healthy and AD

NCT ID: NCT04174651

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2022-07-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Participants with AD with MRI

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.

Group Type: EXPERIMENTAL

Trier Social Stress Test (TSST)

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Healthy Participants 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.

Group Type: EXPERIMENTAL

Trier Social Stress Test (TSST)

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Interventions

Trier Social Stress Test (TSST)

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

Landscape Video

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Hideki Mochizuki

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hideki Mochizuki, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20190833

Identifier Type: -

Identifier Source: org_study_id