Montage of HTDCS in Psycho-cognitive Functions in FM

Last updated: May 12, 2021
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT04890964
36995020.3.0000.5327
  • Ages 30-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 30 to 65 years; who can read and write, with a confirmed diagnosis of FMaccording to the criteria of the American College of Rheumatology (2010-2016). Painscore equal to or greater than six on the Numeric Pain Scale (NPS 0-10) on most daysin the last 3 months.

Exclusion

Exclusion Criteria:

  • Living outside Porto Alegre area and pregnancy.
  • Contraindications to TMS and tDCS: metallic implant in the brain; medical devicesimplanted in the brain, cardiac pacemaker; aneurysmal clip; metallic cochlearprosthesis, ear implants, and non-removable hearing aids; infusion pumps (includingimplantable); 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

Total Participants: 66
Study Start date:
February 01, 2021
Estimated Completion Date:
December 10, 2022

Study 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.

Connect with a study center

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90.450-120
    Brazil

    Active - Recruiting

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