Cortical Plasticity in a Complex Intervention for Endometriosis
Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 6, 2017
January 1, 2017
2.8 years
March 23, 2011
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain function
Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.
12 weeks
Secondary Outcomes (5)
Reduction of pain
12 weeks
Pain scores
12 wks
Quality of life
12 wks
Endometriosis-related symptoms
12 wks
HRV (HF, LF, LF/HF)
12 wks
Study Arms (2)
Treatment
EXPERIMENTALThis group will be treated with SART.
No treatment
NO INTERVENTIONThis group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Jenalead
- Technical University of Munichcollaborator
Study Sites (2)
Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie
Jena, 07743, Germany
Frauenklinik der Technischen Universität München
München, 81675, Germany
Related Publications (2)
Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1134-1142. doi: 10.1097/AOG.0000000000001691.
PMID: 27741200RESULTBeissner F, Preibisch C, Schweizer-Arau A, Popovici RM, Meissner K. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: The Role of the Anterior Hippocampus. Biol Psychiatry. 2018 Nov 15;84(10):734-742. doi: 10.1016/j.biopsych.2017.01.006. Epub 2017 Jan 16.
PMID: 28258747DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Florian Beissner, Dr.phil.nat.
Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. phil. nat.
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 24, 2011
Study Start
March 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 6, 2017
Record last verified: 2017-01