Montage of HTDCS in Psycho-cognitive Functions in FM
- Conditions
- Fibromyalgia
- Interventions
- Device: Transcranial Direct Current Stimulation (tDCS)
- Registration Number
- NCT04890964
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 66
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC Transcranial Direct Current Stimulation (tDCS) Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC Transcranial Direct Current Stimulation (tDCS) Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1 Transcranial Direct Current Stimulation (tDCS) Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1 Transcranial Direct Current Stimulation (tDCS) Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil