Montage of HTDCS in Psycho-cognitive Functions in FM

NCT ID: NCT04890964

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-10

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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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tDCS Non Invasive Brain Stimulation (NIBS)

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolnei Caumo, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Wolnei Caumo, Dr.

Role: CONTACT

+555199813977

Facility Contacts

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Wolnei Caumo, PhD

Role: primary

+5551 3359 6377

Other Identifiers

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36995020.3.0000.5327

Identifier Type: -

Identifier Source: org_study_id

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