Montage of HTDCS in Psycho-cognitive Functions in FM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mapping the Impact of the Montage of the Transcranial Direct Current Stimulation at Home at Cortical and Psycho-cognitive Functions, Functional Capacity and Biological Rhythm in the Fibromyalgia: A Randomized, Factorial, Clinical Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC<br>Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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<br>* Other names: Non Invasive Brain Stimulation (NIBS);|
| Sham Comparator: Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC<br>Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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<br>* Other names: Non Invasive Brain Stimulation (NIBS);|
| Active Comparator: Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1<br>Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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<br>* Other names: Non Invasive Brain Stimulation (NIBS);|
| Placebo Comparator: Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1<br>Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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<br>* Other names: Non Invasive Brain Stimulation (NIBS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Pre and Pos 20 days Intervention | 
| Effect of tDCS over DLPFC on cognitive function. | Cortical connectivity | Pre and Pos 20 days Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, tDCS, fibromyalgia, chronic pain, BDNF, cortical connectivity