Fibromyalgia Clinical Trial
Official title:
Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients. Phase II, Randomized, Double-blind, Single-center Clinical Trial
NCT number | NCT02652988 |
Other study ID # | 14-0471 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | June 12, 2018 |
Verified date | August 2018 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 12, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Brazil | Wolnei Caumo | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Wolnei Caumo |
Brazil,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain level in fibromyalgia patients using home-based tDCS | Evaluate the level of pain in fibromyalgia patients before and after each home-based tDCS session. We will use numerical pain scale to do that. | Ffive days per week, during 12 weeks. | |
Secondary | Serum levels of Brain Derived Neurotrophic Factor (BDNF) | Measurement of serum levels of BDNF pre and pos application of home-based application of home-based tDCS | 2 days | |
Secondary | Serum levels of calcium-binding protein B (S100B) | Measurement of serum levels of S100B pre and pos application of home-based tDCS | 2 days | |
Secondary | Functional capacity | Measurement of functional capacity pre and pos application of home-based tDCS with functional capacity scale in chronic pain. | 2 days | |
Secondary | Catastrophic thinking | Measurement of catastrophic thinking pre and pos application of home-based tDCS with catastrophizing scale. | 2 days |
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