Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients
CompletedNot applicableNCT02652988
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 eval…
Study details
- Official title
- Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients. Phase II, Randomized, Double-blind, Single-center Clinical Trial
- Conditions
- Interventions
- Other: Active-tDCS
- Other: Sham-tDCS
- Sponsor
- Wolnei Caumo
- Organization
- Hospital de Clinicas de Porto Alegre
- Start date
- 2016-01
- Primary completion
- 2018-05-01
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * have chronic pain fibromyalgia according to the criteria of the American College of Rheumatology * Pain unresponsive to analgesics such as paracetamol, acetyl salicylic acid, Ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and Codeine * Give informed consent to participate after initial evaluation. Exclusion Criteria: * Pregnancy * Treatment with carbamazepine and gabapentin * The. Metallic implant in the brain * Medical devices implanted in the brain * Alcohol or drug abuse history in the last 6 months * Suffering from severe depression (with score\> 30 on the Beck Depression Inventory) * History of neurological disorders * Unexplained fainting History * History of head trauma or momentary loss of consciousness (self reported) * Neurosurgery History * Decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, renal failure and hepatitis).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02652988