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Montage of HTDCS in Psycho-cognitive Functions in FM (HFTDCS)

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ClinicalTrials.gov Identifier: NCT04890964
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Triple (Participant, Care Provider, 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
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC
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)
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
Other Names:
  • tDCS
  • Non Invasive Brain Stimulation (NIBS)
Sham Comparator: Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC
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)
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
Other Names:
  • tDCS
  • Non Invasive Brain Stimulation (NIBS)
Active Comparator: Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1
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)
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
Other Names:
  • tDCS
  • Non Invasive Brain Stimulation (NIBS)
Placebo Comparator: Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1
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)
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
Other Names:
  • tDCS
  • Non Invasive Brain Stimulation (NIBS)


Outcome Measures
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Primary Outcome Measures :
  1. level of pain [ Time Frame: 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 :
  1. Psychocognitive functions [ Time Frame: Pre and Pos 20 days Intervention ]
    episodic memory measured by Rey Verbal test

  2. circadian rhythmicity [ Time Frame: Pre and Pos 20 days Intervention ]
    urinary 6-sulfatoxymelatonin levels

  3. Effect of tDCS over DLPFC on cognitive function. [ Time Frame: Pre and Pos 20 days Intervention ]
    Cortical connectivity


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890964


Contacts
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Contact: Wolnei Caumo, Dr. +555199813977 wcaumo@hcpa.edu.br

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
Contact: Wolnei Caumo, PhD    +5551 3359 6377    wcaumo@hcpa.edu.br   
Principal Investigator: Wolnei Caumo, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Wolnei Caumo, Dr Hospital de Clinicas de Porto Alegre
More Information
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04890964    
Other Study ID Numbers: 36995020.3.0000.5327
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
fibromyalgia
chronic pain
tDCS
 TMS
BDNF
cortical connectivity
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases