Cortical Excitability Modulation With ctDCS in Fibromyalgia.
92 patients around the world
Available in Brazil
The prevalence of fibromyalgia is approximately 2.7%, with a female-to-male ratio of 3:1.
Although it is a relatively common syndrome, there are many doubts regarding its diagnosis
and pathophysiology. In addition to the previously mentioned questions, this pathology has
high social costs due to its association with the loss of labor productivity and it is
characterized by being unresponsive to pharmacological treatment. Given the limited
effectiveness of available therapeutic options, new therapeutic and diagnostic options have
been sought. This scenario includes the use of different techniques of non-invasive brain
stimulation, such as transcranial direct current magnetic stimulation (tDCS) and transcranial
magnetic stimulation (TMS), which have already had promising results in reducing pain. In
addition, TMS also allows measuring parameters that help to understand the reorganization of
physiological processes. In this study, TMS is used to understand the pathophysiology of
fibromyalgia, while tDCS allows modulating the excitability of the neuronal membrane
potential of cortical and subcortical neural networks, producing a neuromodulatory effect of
the top-down type. According to the evidence, the greatest impact on pain is associated with
stimulation of the primary motor cortex (M1), but recent studies have shown the possible
relationship between stimulation of extracerebral regions such as the cerebellum, with an
analgesic effect present in healthy individuals and patients with different pathologies. In
the same way, the cortical excitability measures obtained through TMS allow us to identify
the imbalance between inhibitory and excitatory systems, related to pain perception and the
analgesic response of endogenous mechanisms. In this research, our objective is to evaluate
the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in
patients with fibromyalgia. This is a randomized, double-blind, controlled clinical trial,
parallel, which has as its primary outcome, the evaluation of the variations in motor evoked
potential (MEP) (neurophysiological outcome) and the numerical pain scale (NPS) as a clinical
outcome. Secondary outcomes include the silent period (CSP), intra-cortical facilitation
(ICF) and intra-cortical inhibition (ICI) obtained through TMS, the function of the
descending modulatory path of pain by the conditioned modulation test (CPM test), the Brief
Pain Inventory (BPI) and the pain thresholds by heat, pressure and cold. The intervention
consists of a single tDCS session in which two devices will be used simultaneously. The
active electrode will be placed in the cerebellum and/or in the primary motor cortex (4
stimulation protocols that will be implemented; active cerebellum electrode - active M1
electrode, sham cerebellum electrode - active M1 electrode, active cerebellum-M1 sham
electrode, sham cerebellum electrode-M1 sham electrode) and the cathode in the contralateral
supraorbital region. The equipment will apply a current of 2 mA for 20 minutes. In total,
there will be 92 patients, divided into 4 intervention blocks and composed of 23 individuals
each.