Clinical Trials Directory

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

TypeNameDescription
PROCEDURESpecific 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.