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

May 12, 2021 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 60 minutes before and after tDCS stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychocognitive functions
Time Frame: Pre and Pos 20 days Intervention
episodic memory measured by Rey Verbal test
Pre and Pos 20 days Intervention
circadian rhythmicity
Time Frame: Pre and Pos 20 days Intervention
urinary 6-sulfatoxymelatonin levels
Pre and Pos 20 days Intervention
Effect of tDCS over DLPFC on cognitive function.
Time Frame: Pre and Pos 20 days Intervention
Cortical connectivity
Pre and Pos 20 days Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Wolnei Caumo, Dr, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

December 10, 2021

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36995020.3.0000.5327

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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