Effect of tDCS in Intrinsic Functional Brain Connectivity Assessed by Functional Magnetic Resonance in Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT03841227|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: Active-tDCS Device: Sham-tDCS||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Active Comparator: Active-tDCS
10 patients will receive Active-tDCS intervention (2mA, 20 min) at home.
Active home-based tDCS applied at home. 5 days a week for 4 weeks.
Sham Comparator: Sham-tDCS
10 patients will receive Sham-tDCS intervention (2mA, 20 min) at home.
Sham home-based tDCS applied at home. 5 days a week for 4 weeks.
- Change from Baseline Functional cerebral connectivity(rs-fMRI)to post-intervention rs-fMRI [ Time Frame: 30 minutes ]Evaluation of functional cerebral connectivity using resting-state functional magnetic resonance imaging (rs-fMRI) between the change in baseline and post-intervention assessments.
- Structural cerebral connectivity [ Time Frame: 30 minutes ]Evaluation of structural cerebral connectivity using diffusion tract imaging (DTI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841227
|Contact: Wolnei Caumo, PhD||+5551 3359 firstname.lastname@example.org|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120|
|Contact: Wolnei Caumo, PhD +5551 3359 8083 email@example.com|
|Principal Investigator: Wolnei Caumo, PhD|
|Sub-Investigator: Matheus D Soldatelli, MD|
|Hospital de Clinicas e Porto Alegre (HCPA)||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003|
|Contact: Wolnei Caumo 55 51 99813977 firstname.lastname@example.org|
|Principal Investigator: Wolnei Caumo|
|Principal Investigator:||Wolnei Caumo, PhD||Federal University of Rio Grande do Sul|