Brief Summary

'Mind and Skin': A prospective cohort study evaluating the impact of inflammation, itch and sleep disturbance on the brain, mental health and cognition, in patients with severe atopy.

Conditions

• Atopic Dermatitis

Intervention / Treatment

• Drug: Methotrexate
• Drug: Dupilumab

Primary Outcome Measures

• Eczema Area and Severity Index (EASI) Score (6 months)
  Clinical assessment of atopic dermatitis disease activity. Range 0-72 (72 being the most severe outcome)
• Peak Pruritus Numerical Rating Score (6 months)
  Patient reported itch severity. Range 0-10 (10 being the worst outcome)
• Transepidermal water loss (TEWL) (6 months)
  Skin barrier function measurement using a device which measures the amount of water that passively evaporates through skin to the external environment due to water vapor pressure gradient on both sides of the skin barrier
• Skin surface pH (6 months)
  Skin barrier function measurement using a pH measuring device.
• Metabolome swab (6 months)
  Skin metabalome analysis using a skin swab
• Skin ELISA (enzyme-linked immunosorbent assay) and serum ELISA (6 months)
  Immunoassay detection and quantification
• RNA sequencing of blood serum (6 months)
  To detect transcript isoforms, gene fusions and single nucleotide variants.
• Pediatric Sleep Questionnaire (6 months)
  Sleep questionnaire. Score 18-126 (126 being the worst clinical outcome)
• Morningness-Eveningness Questionnaire (6 months)
  Sleep questionnaire. Score 16-86 assesses individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day.
• Patient-Reported Outcomes Measurement Information System (PROMIS) (6 months)
  Sleep questionnaire. Score 0-20 (0 being the worst clinical outcome)
• Pittsburgh Sleep Quality Index (6 months)
  Sleep questionnaires. Score 0-21 (21 being the worst clinical outcome)
• Dreem headband electroencephalogram monitoring (6 months)
  Sleep study - Measures brain activity to assess sleep cycles
• Polysomnography (6 months)
  Sleep study incorporating electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances.
• Actigraphy Watch analysis (6 months)
  Watch is worn by participant which records movement during sleep to analyse sleep pattern
• EMFIT mattress analysis (6 months)
  Mattress sensor which records movement during sleep to analyse sleep pattern to analyse sleep pattern
• Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II) Score (6 months)
  Intelligence Quotient Test. Score 40-160 (40 being the worst clinical outcome)
• Go/No-GO Task (6 months)
  The Go/No-go task requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials. This is scored as a fraction of correct responses.
• Simon Task (6 months)
  In this task participants are asked to respond to visual stimuli by making a rightward response to one stimulus (e.g. a circle) and a leftward response to another (e.g. a square). This is scored as a fraction of correct responses.
• Continuous Performance Task (6 months)
  In this task participants are asked to only respond to a specific sequence of visual stimuli. This is scored as a fraction of correct responses.
• Time Discrimination Task (6 months)
  In this task participants are ask to decide which stimuli stayed on screen for the longest duration. This is scored as a fraction of correct responses.
• Vigilance Task (Mackworth Clock) (6 months)
  In this task participants are asked to watched a clock hand that moves every second around the clock. From time to time the hand skips a second and participants need to respond to this. This is scored as a fraction of correct responses.
• Performance on Working Memory Task (6 months)
  Completed in functional MRI
• Performance on Sustained Attention Task (6 months)
  Completed in functional MRI
• Resting Brain State (6 months)
  Measured in functional MRI
• Structural Changes in the Brain (6 months)
  Structure of the brain is measured in MRI

Countries

United Kingdom

Locations and Investigators

• Unit for Paediatric and Population-based Dermatology Research, London, United Kingdom (Recruiting)
  • Carsten Flohr