Trials / Completed
CompletedNCT01321840
Cortical Plasticity in a Complex Intervention for Endometriosis
Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Jena · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Specific Autoregulation Therapy (SART) | Complex intervention involving acupuncture and hypnotherapeutic techniques after an extensive diagnosis using chinese medical concepts. Patients will receive a maximum of 10 treatments, which are delivered weekly. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-03-24
- Last updated
- 2017-01-06
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01321840. Inclusion in this directory is not an endorsement.