Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Brain function
Study Overview
Brief Summary
The aim of the study is to test, if patients suffering from Endometriosis show changes in their brain function, when being treated with SART (Systemic Autoregulation Therapy), a complex intervention consisting of interventions from Traditional Chinese Medicine (TCM) and Western Hypnotherapy. Functional and structural brain changes are assessed using Magnetic Resonance Imaging data which are analyzed by means of voxel-based morphometry (VBM), connectivity and perfusion analysis. A third outcome measure are changes of patients' heart rate variability, indicating the activity of their autonomic nervous system.
With a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation regularity, dyspareunia, defecation pain, and quality of life are assessed during the SART treatment.
During the treatment, we expect to see changes in cortical thickness, functional connectivity and perfusion of pain-related areas of the cortex, that correlate with the changes in heart rate variability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 18 years old
- •clinically or histologically ensured diagnosis of Endometriosis
- •preoperative and postoperative recurring ailments related to Endometriosis
- •no hormone therapy (GnRH analogues, contraceptives)
- •sufficient understanding of the German or English language
- •persisting pain during menstruation (also in between)
- •voluntary participation after information on the possible benefits and risks of the examination and intervention
- •written informed consent
Exclusion Criteria
- •alcohol addiction, drug addiction
- •pregnancy
- •diseases and other criteria, preventing an MRI examination:
- •pacemaker
- •neurostimulator or drug pump
- •metal parts in the body (implants, splinters, etc.)
- •claustrophobia
Outcomes
Primary Outcomes
Brain function
Time Frame: 12 weeks
Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.
Secondary Outcomes
- Reduction of pain(12 weeks)
- Quality of life(12 wks)
- Pain scores(12 wks)
- Endometriosis-related symptoms(12 wks)
- HRV (HF, LF, LF/HF)(12 wks)
Investigators
Florian Beissner
Dr. phil. nat.
University of Jena