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Report for Clinical Trial NCT03843203
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Efficacy and Effectivity of Long Term Home Based tDCS in Fibromyalgia: an Explanatory Randomized Clinical Trial
Fibromyalgia(FM) is a widespread musculoskeletal pain syndrome characterized by fatigue, sleep disorders, cognitive impairment, depressive symptoms and neuro-vegetative symptoms. It is a multivariable and complex neurobiological process. FM worldwide prevalence according to American College of Rheumatology (ACR) 2010 diagnostic criteria is estimated under 5,4%. In USA the burden caused by FM is estimated at 29 billions every year, due to assistance, health care costs and retirement to loss of productivity. It is known that conventional pharmacological approaches present poor therapeutic response in more than 50% of these patients. It is conceivable that this limited results, at least in part, due to the lack of a complete elucidation of its pathophysiology. Our hypothesis is that tDCS has a superior effect on clinical outcomes, functional capacity, cortical excitability, and psycho-affective functions compared to simulated treatment. In order to respond to the objectives of this study, a randomized, parallel-blinded clinical trial will be conducted. FM patients will be randomized to receive tDCS with anodic pole on the primary motor cortex and the cathode pole on the contralateral prefrontal cortex.
NCT03843203 Fibromyalgia Transcranial Direct Current Stimulation MeSH:Fibromyalgia Myofascial Pain Syndromes
1 Interventions
Name: Transcranial Direct Current Stimulation - tDCS
Primary Outcomes
Description: Change from before and after the First phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)
Measure: Change in pain level - first phase Time: 1 monthDescription: Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)
Measure: Change in functional capacity - first phase Time: 1 monthSecondary Outcomes
Description: Change from before and after the Second phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)
Measure: Change in pain level - second phase Time: 3 monthsDescription: Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)
Measure: Change in functional capacity - second phase Time: 3 monthsDescription: Change from before and after the First phase of treatment on the score in a numerical pain scale (NPS 0-10) for a moderate heat pain stimulus to the right arm (ventral region) during a conditioned pain modulation task (CPM-task), where participant keeps the counter-lateral hand in an iced cold water (0 to 1ยบ Celsius)
Measure: Change in Function of modulatory descending system Time: 1 monthDescription: Change from before and after the First phase of treatment on measures of motor threshold (MT), motor evoked potential (MEP), intracortical facilitation (ICF), short intracortical inhibition (SICI), and cortical silent period (CSP) assessed with transcranial magnetic stimulation (TMS).
Measure: Change in Function of corticospinal pathway Time: 1 monthDescription: Blood samples will be collected at baseline and after the First phase of intervention in order to determine BDNF serum levels using a standardized kit
Measure: Change in levels of Brain derived neurotrophic factor - BDNF Time: 1 monthDescription: Blood samples will be collected at baseline in order to determine BDNF gene polymorphism for the G allele (rs6265)
Measure: Polymorphism of Brain derived neurotrophic factor - BDNF Time: 10 minutesPurpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs6265
Blood samples will be collected at baseline in order to determine BDNF gene polymorphism for the G allele (rs6265).