HealthyNCT04174651
Stress-induced Scratching in Healthy and AD
A study testing Trier Social Stress Test (TSST) and Landscape Video in people with Healthy and Atopic Dermatitis, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Atopic Dermatitis
- What is being tested?
- Trier Social Stress Test (TSST) and Landscape Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cerebral Mechanism of Stress-Induced Spontaneous Scratching in Healthy Volunteers and Patients With Atopic Dermatitis (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).
- Conditions
- Healthy, Atopic Dermatitis
- Being tested
- Trier Social Stress Test (TSST), Landscape Video
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress Test (TSST)Behavioural
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 VideoBehavioural
Participants randomized to receive the control condition will be watching a landscape video for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Trier Social Stress Test (TSST); Behavioral: Landscape Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 15 minutes
Secondary outcomes (1)
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).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start27 Jan 2020
- Primary completion28 Apr 2021
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover randomization within the arms.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideki Mochizuki, University of Miami
- Investigators
- Hideki Mochizuki, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174651
- Sponsor's protocol ID
- 20190833
- Status last verified
- Aug 2022
- First submitted
- 10 Oct 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cerebral Mechanism of Stress-Induced Spontaneous Scratching in Healthy Volunteers and Patients With Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT04174651
- Acronym / sponsor ID
- 20190833
- Conditions
- Healthy, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover randomization within the arms.
| Arm | Type | Receives |
|---|---|---|
| Participants with AD with MRI | Experimental | Behavioral: Trier Social Stress Test (TSST), Behavioral: Landscape VideoParticipants 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 | Experimental | Behavioral: Trier Social Stress Test (TSST), Behavioral: Landscape VideoHealthy 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Healthy Participants with MRI, Participants with AD with MRI |
| Landscape VideoParticipants randomized to receive the control condition will be watching a landscape video for 10 minutes. | Behavioural | Healthy Participants with MRI, Participants with AD with MRI |
Primary outcome
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).
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.
1 secondary outcome
Correlation of perceived stress with stress-induced brain activity
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideki Mochizuki, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test (TSST) and Landscape Video in people with Healthy and Atopic Dermatitis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain activity (time frame: Baseline, 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.