Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder
NCT04566783 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52
Last updated 2023-03-23
Summary
Investigation of (possible etiological) factors associated with PGAD symptomatology as well as description of comorbid disorders subjects with PGAD.
Persistent genital arousal disorder (PGAD) is a presumably rare, although debilitating condition, which was first defined at the beginning of this century and has not yet found consideration by any of the international classification systems of diseases. PGAD is commonly characterized by persistent and unwanted sensations of genital arousal which are not related to subjective feelings of sexual desire or arousal. Affected patients which are predominantly women can suffer tremendously. The lack of basic research on the etiology of PGAD leads to insufficient therapeutical approaches.
Conditions
- Restless Genital Syndrome
- Sexual Arousal Disorder
- Orgasmic Disorder
- Psychosexual Disorder
Interventions
- DIAGNOSTIC_TEST
-
Psychological/psychiatric examination
Thorough diagnostic and (neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS) as well as questionnaires assessing sexual function (e.g. SIS/SES), depression and anxiety (HADS), childhood trauma (CTQ) and life quality (WHOQOL-BREF). In a semi-structured interview sociodemographic data, drug history and sexual characteristics are captured.
- DIAGNOSTIC_TEST
-
Neurological examination
Standardized clinical neurological examination as well as neurophysiological measurements (Pudenus-SEP, ENoG, clinical EEG).
- DIAGNOSTIC_TEST
-
Gynecological/urological examination
Standard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors).
- DIAGNOSTIC_TEST
-
Laboratory assessment
Blood sample will be analyzed to evaluate (epi-)genetic markers of increased central excitability or decreased inhibition including specific parameters of the serotonin-, dopamine- and endocannabinoid system.
- DIAGNOSTIC_TEST
-
Structural and Functional Magnetic Resonance Imaging
1. Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices). 2. Structural MRI of the lumbosacral spinal cord to look for any pathologies on the spinal level, especially spinal level S2-4 (e.g. Tarlov cysts). 3. High-resolution structural MRI (T1) including brain stem will be applied to all participants in order to explore alterations in gray matter volume or density. 4. Structural differences in white matter will be assessed using a high-resolution DTI sequence. In addition to standard voxel-wise comparison of DTI derived parameters for white matter microstructural integrity, a tractography-based analysis will test for alterations in structural connectivity. 5. Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC). 6. Functional MRI to assess brain response towards sexual cue reactivity.
Sponsors & Collaborators
-
Hannover Medical School
lead OTHER
Principal Investigators
-
Tillmann Prof. Krüger, MD · Hannover Medical School
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-01
- Primary Completion
- 2021-08-30
- Completion
- 2023-01-01
Countries
- Germany
Study Locations
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