Effect of tDCS in Intrinsic Functional Brain Connectivity Assessed by Functional Magnetic Resonance in Fibromyalgia
Effect of Transcranial Continuous Current Neuromodulation in Intrinsic Functional Brain Connectivity Assessed by Functional Magnetic Resonance Imaging (fMRI) in Fibromyalgia: A Randomized, Double-blind Controlled Trial
1 other identifier
interventional
20
1 country
2
Brief Summary
Considering the central component of fibromyalgia (FM), the focus of research on current therapeutic approaches has been techniques that may modify the dysfunctional neuroplasticity process, such as transcranial direct current (tDCS) stimulation in order to counteract the dysfunction responsible for triggering and maintain the symptoms of FM. Although this technique is gaining space in research and in the clinical scenario, many questions remain to be answered, such as time of treatment, place to be stimulated and neurophysiological clarification of the mechanisms involved. Based on the presented scenario, the present project was organized, being a double-blinded parallel randomized controlled trial with 20 female patients with FM diagnosed according to the criteria of the American Society of Rheumatology (2010 - reviewed in 2016) between 19 and 65 years of age, randomized to receive active or simulated anodic pole over the left dorsolateral prefrontal cortex (DLPFC) (10 patients in each group). Twenty 20-minute sessions, with a current intensity of 2 milliamperes, will be performed. In order to respond to the objectives of this study, the IFC will be evaluated before and after the intervention, through rs-fMRI using seed-based correlation analysis (SCA). The investigators have a secondary objective to correlate structural connectivity through the technique of diffusion tensors imaging (DTI) with measures of pain, functional capacity, depressive symptoms and catastrophism to pain. The hypothesis is that in FM there is a syndrome of dysfunction in basal intrinsic functional connectivity (IFC) and that the tDCS has a neuromodulatory effect capable of reducing connectivity between brain areas related to chronic pain and other neuropsychiatric components of FM, such as the ventrolateral thalamus, cortex motor, prefrontal cortex, insular cortex, hippocampus, periaqueductal gray matter, among others. The investigators believe that a higher cortico-thalamic IFC and between regions with high density of opioid receptors have a positive predictive response in the treatment of tDCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
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
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 4, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFebruary 15, 2019
February 1, 2019
1.3 years
August 4, 2018
February 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Functional cerebral connectivity(rs-fMRI)to post-intervention rs-fMRI
Evaluation of functional cerebral connectivity using resting-state functional magnetic resonance imaging (rs-fMRI) between the change in baseline and post-intervention assessments.
30 minutes
Secondary Outcomes (1)
Structural cerebral connectivity
30 minutes
Study Arms (2)
Active-tDCS
ACTIVE COMPARATOR10 patients will receive Active-tDCS intervention (2mA, 20 min) at home.
Sham-tDCS
SHAM COMPARATOR10 patients will receive Sham-tDCS intervention (2mA, 20 min) at home.
Interventions
Eligibility Criteria
You may qualify if:
- Literate
- Female, between 18 and 65 years old
- With the diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (2010-2016)
- Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months.
- Give informed consent to participate after the initial evaluation.
You may not qualify if:
- Living outside the city of Porto Alegre, RS, Brazil
- Pregnancy
- Severe Mental Illness
- tDCS contraindications
- Magnetic resonance imaging (MRI) contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil
Hospital de Clinicas e Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolnei Caumo, PhD
Federal University of Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor at the Post-Graduation Program in Medical Sciences, Faculty of Medicine, UFRGS
Study Record Dates
First Submitted
August 4, 2018
First Posted
February 15, 2019
Study Start
August 1, 2018
Primary Completion
December 1, 2019
Study Completion
March 1, 2020
Last Updated
February 15, 2019
Record last verified: 2019-02