Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Observational

Summary: 
      The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients
      using functional and structural brain imaging together with genetic, physiological, and
      biological parameters.
    

Detailed description: 
      Vulvodynia (VD) is a chronic pain disorder affecting up to 15% of women and resulting in
      substantial impairment in health-related quality-of-life. The treatment of the disorder is
      hampered by a lack of knowledge regarding its neurobiological basis. The proposed study is
      based on the general hypothesis that like other persistent pain conditions, VD clinical
      phenotypes (characteristic of the disorder) are composed of multiple biological
      endophenotypes (such as an hereditary characteristic that is normally associated with a
      condition but not a direct symptom of that condition) and that meaningful subgroups can be
      identified.

      In the current proposal, the investigators plan to extensively phenotype a large sample of VD
      patients using functional and structural brain imaging together with genetic, physiological,
      and biological parameters. The hypothesis is that central mechanisms (including alterations
      in the processing/modulation of interoceptive signals from the external genitals) are
      important determinants of the clinical presentation, and that differences in these brain
      signatures could play an important role in treatment responsiveness. Such phenotyping has
      considerable implications for future drug development.

      There will be a total of 100 females diagnosed with either generalized vulvodynia (GVD) or
      provoked vestibulodynia (PVD) which is similar however more localized to just the vestibule
      area of the vulva enrolled. It will be a total of 140 with PVD and 60 with GVD.

      The study will involve 2 visits total over about 1-3 weeks depending on schedules and
      menstrual cycle. The investigators will not scan a person if menstruating AND having
      abdominal cramps/emotional liability as this may confound analysis.

      The participant will be screened for inclusion /exclusion criteria. After signing the consent
      the participant will have a history and physical and brief psychological interview to
      evaluation for any psychological problems present (using standard DSM-IV (diagnostic and
      statistical manual for mental disorders) criteria. The participant will completed
      questionnaires to assess mood, pain, pain related behavior and sexual functioning on Survey
      Monkey. The participant will have a neuro-sensory evaluation of the perineum performed by a
      qualified gynecologist Medical Doctor or Nurse Practitioner. During the examination the
      clinician will swab the vaginal canal using 2 sterile swabs (vaginal fluid) for microbiota
      (normal vaginal healthy bacteria). There will be 1 venous blood draw of about 2 teaspoons via
      venipuncture by the nurse, to look at blood metabolites and genes. Then the participant will
      have discomfort threshold testing of the right and left shin and upper arm muscle with an
      algometer.

      Following screening the participant will return within 1-3 weeks to have brain scanning done
      which involves both functional (resting state) and structural scans. The investigators will
      measure changes in the autonomic nervous system simultaneously through electrodes on finger
      tips which measure minute changes in sweat glands. Saliva samples will be collected for
      analysis of polymorphism in genes controlling inflammation, pain, and nerve functioning.
      Prior to the scanning the participant will be asked to complete questionnaires to assess
      current (state) mood and symptoms on Survey Monkey.

      The length of time of each visit is assessed to be about 90 minutes each.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women 18-55 yo with vestibulodynia, and or generalized vulvodynia, characterized by at
        least 3 months history of pain, burning, or irritation, with an intensity of 4/10 or
        greater, of the vulva localized to the vestibule (vestibulodynia) with or without pain
        located in outer region of the vulva (generalized VD).

        The pain must NOT be attributable to current bacterial, fungal, or yeast infections, a skin
        condition (eg; dermatitis), hormonal changes, or vaginitis.
      
Biospecimen description: 
      saliva samples
    
Keywords: Vulvodynia; Endophenotypes; functional MRI