Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes — Vulvodynia  

Vulvodynia Clinical Trial

Official title: Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Vulvodynia

• NCT number: NCT02733172
• Study type: Observational
• Source: University of California, Los Angeles
• Status: Completed
• Start date: July 2013
• Completion date: June 30, 2018