Montage of HTDCS in Psycho-cognitive Functions in FM

NCT04890964 | Unknown

• 1 other identifier: 36995020.3.0000.5327
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; chronic pain; tDCS; TMS; BDNF; cortical connectivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Psychocognitive functions

  Pre and Pos 20 days Intervention

• circadian rhythmicity

  Pre and Pos 20 days Intervention

• Effect of tDCS over DLPFC on cognitive function.

  Pre and Pos 20 days Intervention

Study Arms (4)

Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC

ACTIVE COMPARATOR

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)

Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC

SHAM COMPARATOR

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)

Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1

ACTIVE COMPARATOR

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)

Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1

PLACEBO COMPARATOR

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)

Interventions

Transcranial Direct Current Stimulation (tDCS) 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

Also known as: tDCS, Non Invasive Brain Stimulation (NIBS)

Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC; Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1; Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC; Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, Dr

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolnei Caumo, Dr.

CONTACT

+555199813977; wcaumo@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HB-a-tDCS - M1 (n=33); HB-s-tDCS - M1 (n=17); HB-a-tDCS-DLPFC (n=33); HB-a-tDCS- DLPFC (n=17)

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: May 18, 2021
• Study Start: February 1, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2022
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

BR (1)