Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this phase II, randomized, double-blind clinical trial, the investigators intended to
      evaluate the home-based effect of transcranial direct current stimulation (tDCS) in patients
      with fibromyalgia. This syndrome affects between 3-5% of the population in an age group 40-60
      years also occurring in childhood and old age. Reaches 3.4% of women and 0.5% of men.
      Fibromyalgia is a chronic widespread pain syndrome in various parts of the body. The
      neuromodulation techniques have as a principle produce inhibition or cortical arousal. The
      tDCS is a non-invasive brain stimulation method used to modulate the cortical excitability,
      using a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode
      electrodes. The current reaches the cortex, producing hyperpolarization or depolarization of
      the axonal membrane potential. Evidence has shown that this method is presented as a
      technique able to alter cortical and subcortical neural networks. This technique has been
      used to treat psychiatric disorders such as depression, acute mania, bipolar affective
      disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal,
      rehabilitation after stroke, pain syndromes such as neuropathic pain, migraine, pancreatitis
      pain chronic and fibromyalgia. The tDCS is a low cost technique, with virtually no side
      effects and which exerts therapeutic effect by neuromodulatory pathways by distinct pathways
      activated by the drugs. In this scenario falls within the importance of developing this
      device for home use by fibromyalgia patients, since it is easy to use and thereby enables
      maintaining the benefit observed in studies performed and supervised frequently used in care
      centers. The use of tDCS over the long term is not feasible in hospital by patients demands,
      sometimes every day or more than once a week, removing the patient from their activities, and
      cost shifting and overload the healthcare system. Therefore, the objective of this study is
      to evaluate the effect of home-based tDCS in fibromyalgia patients in long-term treatment.
    

Detailed description: 
      Will be included women aged between 18 and 65 years, chronic pain fibromyalgia according to
      the criteria of the American College of Rheumatology, pain unresponsive to analgesics such as
      paracetamol, acetylsalicylic acid, ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and
      Codeine. And give informed consent to participate after initial evaluation. Primary outcome
      is to evaluate the effect of treatment with home-base tDCS in patients with fibromyalgia.
      Secondary outcomes are: compare the effect of active home-based tDCS and sham in cortical
      neurophysiological processes and subcortical to stimulation with TMS and standardized noxious
      stimuli with and without concomitant conditioned Pain Modulation (CPM) in pain threshold
      outcomes to the test mechanical pressure, heat-algesic stimulus, cortical excitability
      parameters [evoked rest motor (MEP) MEP enough to evoke amplitude of 1 mV peak to peak,
      silent period (SP), motor threshold (MT), variation in blood volume and oxygenation cortical
      motor area [oxy-hemoglobin concentrations (Hbo) / deoxy-hemoglobin (HBr)] optically
      functional neuroimaging (NIRS) and variation in the frequency of alpha and beta waves of
      motor area stimulated by tDCS assessed by electroencephalogram (EEG). In surrogate outcome,
      the investigators will compare the effect of active home-sham tDCS the tDCS in pain levels
      and functional capacity, catastrophic thinking, bookmark levels of neurotrophic activity
      (BDNF) and astrocytic (S100 beta).
    

Intervention name(s): Active-tDCS; Sham-tDCS
Intervention type(s): Other; Other
Intervention description(s): Active home-based tDCS applied at home.; Sham home-based tDCS applied at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tDCS; chronic pain; fibromyalgia