Cortical Plasticity in a Complex Intervention for Endometriosis

January 5, 2017 updated by: Florian Beissner, University of Jena

Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie
      • München, Germany, 81675
        • Frauenklinik der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
This group will be treated with SART.
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.
No Intervention: No treatment
This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pain
Time Frame: 12 weeks
Reduction of pain by 50% or more (dichotomous).
12 weeks
Pain scores
Time Frame: 12 wks
Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
12 wks
Quality of life
Time Frame: 12 wks
Changes (ordinal) in the quality of life score as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
12 wks
Endometriosis-related symptoms
Time Frame: 12 wks
Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
12 wks
HRV (HF, LF, LF/HF)
Time Frame: 12 wks
heart rate variability parameters
12 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

Technical University of Munich

Investigators

  • Study Director: Florian Beissner, Dr.phil.nat., Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jena-Endo-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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