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This study aims to map the impact of anodic transcranial direct current stimulation (tDCS) for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia.
This study aims to map the impact of anodic tDCS for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia, targeting the outcomes of the following axes: (1) pain intensity and functional capacity; (2) psycho cognitive functions; (3) neurophysiological markers; (4) biological rhythm markers; (5) to map the potential of neurophysiological markers, biological rhythm and history of trauma in childhood and adolescence in functional capacity, depressive symptoms and working memory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC | Active Comparator | Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
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| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC | Sham Comparator | Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
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| Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1 | Active Comparator | Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
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| Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1 | Placebo Comparator | Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| level of pain | response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus | Up to 60 minutes before and after tDCS stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Psychocognitive functions | episodic memory measured by Rey Verbal test | Pre and Pos 20 days Intervention |
| circadian rhythmicity | urinary 6-sulfatoxymelatonin levels |
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Inclusion Criteria:
Exclusion Criteria:
We have chosen women over men, due to the prevalence of the disease that we are researching and also because the symptoms characteristics are more homogeneous.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolnei Caumo, Dr. | Contact | +555199813977 | wcaumo@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Wolnei Caumo, Dr | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90.450-120 | Brazil |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)
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A randomized, double-blind, factorial, parallel-group, controlled trial with simulated treatment will be performed. The study follows the CONSORT guideline and will be registered in the ClinicalTrials.gov database: Home
|
| Pre and Pos 20 days Intervention |
| Effect of tDCS over DLPFC on cognitive function. | Cortical connectivity | Pre and Pos 20 days Intervention |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |