Montage of HTDCS in Psycho-cognitive Functions in FM

Fibromyalgia Clinical Trial

— HFTDCS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890964
• Other study ID #: 36995020.3.0000.5327
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 10, 2022

Study information

• Verified date: May 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Wolnei Caumo, Dr.
• Phone: +555199813977
• Email: wcaumo[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

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