Fibromyalgia
Conditions
Keywords
fibromyalgia, chronic pain, tDCS, TMS, BDNF, cortical connectivity
Brief summary
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.
Detailed description
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.
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
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
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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
Intervention model description
HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 30 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the criteria of the American College of Rheumatology (2010-2016). Pain score equal to or greater than six on the Numeric Pain Scale (NPS 0-10) on most days in the last 3 months.
Exclusion criteria
* Living outside Porto Alegre area and pregnancy. * Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; aneurysmal clip; metallic cochlear prosthesis, ear implants, and non-removable hearing aids; infusion pumps (including implantable); cranial halos. Pregnant women, shift work, use of exogenous melatonin, history of alcohol or drug abuse in the last 6 months, neurological pathologies, history of head trauma or neurosurgery, decompensated systemic chronic diseases, chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome), personal history of cancer, past or under treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| level of pain | Up to 60 minutes before and after tDCS stimulation | response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychocognitive functions | Pre and Pos 20 days Intervention | episodic memory measured by Rey Verbal test |
| circadian rhythmicity | Pre and Pos 20 days Intervention | urinary 6-sulfatoxymelatonin levels |
| Effect of tDCS over DLPFC on cognitive function. | Pre and Pos 20 days Intervention | Cortical connectivity |
Countries
Brazil
Contacts
Primary ContactWolnei Caumo, Dr.
Outcome results
None listed