- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04451564
Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients (FIBRODOPA)
Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients Using a Mindfulness-based Psychological Intervention: A [18F]-DOPA Positron Emissions Tomography (PET) Study Study Protocol for the FIBRODOPA Study- a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the present study is a multi-center randomized controlled trial (RCT) with 3 time points: before the intervention, after completion of the intervention and 3-months after completion of the intervention. Eighty FM patients will be randomly assigned to either the MORE intervention (N=40) or to a wait-list control group (N=40). Additionally a comparison group of healthy women (N=20) will be enrolled. The MORE intervention consists of eight 2-hour long group sessions administered weekly over a period of 8 weeks. Before and after the intervention, FM participants will undergo [18F] DOPA Positron Emission Tomography (PET) and functional magnetic resonance (MR) imaging while performing a monetary reward task. The primary outcome will be endogeneous DA changes measured with [18F] DOPA PET at baseline, after the intervention (after 8 weeks for control group), and at 3 months' follow-up. Secondary outcomes will be (1) clinical pain measures and FM symptoms using standardized clinical scales 2) functional brain changes 3) measures of negative and positive affect, stress and reward experience in daily life using the Experience Sampling method (ESM) 4) biological measures of stress including cortisol and alpha-amylase.
Design: If the findings of this study confirm the effectiveness of MORE in restoring DA function, reducing pain and improving mood symptoms, MORE can be judged to be a promising means to improve quality of life in FM patients. The findings of this trial may inform health care providers about the potential use of the MORE intervention as a possible non-pharmacological intervention for FM.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: katharina Ledermann
- Phone Number: +41765330316
- Email: katharina.ledermann@unifr.ch
Study Contact Backup
- Name: Maya Burckhard
- Email: maya.burkhard@unifr.ch
Study Locations
-
-
-
Fribourg, Switzerland, 1700
- University of Fribourg
-
Contact:
- Katharina ledermann
- Phone Number: +41765330316 +41765330316
- Email: katharina.ledermann@unifr.ch
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Contact:
- Chantal martin Sölch
- Email: chantal.martinsoelch@unifr.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fibromyalgia syndrome
- no psychiatric disorders
- right handed
- older than 18 years,
Exclusion Criteria:
- male sex
- history of neurological disorders
- left handed
- psychiatric disorders
- current substance or tobacco abuse
- current and past substance dependence
- schizophrenia spectrum disorder
- any other form of chronic pain apart from Fibromyalgia
Study Plan
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: MORE Mindfulness oriented recovery enhancement group
|
8- week psychological program based on mindfulness techniques
|
No Intervention: Control
wait-list
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dopamine response
Time Frame: within the second year
|
Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009
ml g -1 per min
|
within the second year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in pain and clinical related measures
Time Frame: within the second year
|
measured with the brief pain inventory questionnaire (BPI, Cleeland, 1994) Range: 0-40.
0 corresponds to no interference with pain in daily life and 40 corresponds to maximal interference of pain in daily life
|
within the second year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chantal o Martin Sölch, PhD, University of Fribourg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIBRODOPA TRIAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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