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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Fibromyalgia

Treatments: Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04890964

36995020.3.0000.5327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 4 patient groups, including a placebo group

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

Active Comparator group

Description:

Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

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

Sham Comparator group

Description:

Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

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

Active Comparator group

Description:

Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

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

Placebo Comparator group

Description:

Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)