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

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (tDCS)

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, chronic pain, tDCS, TMS, BDNF, cortical connectivity

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Placebo Comparator

Arm Label

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

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

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

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

level of pain

response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus

Secondary Outcome Measures

Psychocognitive functions

episodic memory measured by Rey Verbal test

circadian rhythmicity

urinary 6-sulfatoxymelatonin levels

Effect of tDCS over DLPFC on cognitive function.

Cortical connectivity

Full Information

NCT ID

NCT04890964

First Posted

February 24, 2021

Last Updated

May 12, 2021

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT04890964

Brief Title

Montage of HTDCS in Psycho-cognitive Functions in FM

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

December 10, 2021 (Anticipated)

Study Completion Date

December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

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

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Sham Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

tDCS, Non Invasive Brain Stimulation (NIBS)

Intervention Description

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

Primary Outcome Measure Information:

Title

level of pain

Description

response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus

Time Frame

Up to 60 minutes before and after tDCS stimulation

Secondary Outcome Measure Information:

Title

Psychocognitive functions

Description

episodic memory measured by Rey Verbal test

Time Frame

Pre and Pos 20 days Intervention

Title

circadian rhythmicity

Description

urinary 6-sulfatoxymelatonin levels

Time Frame

Pre and Pos 20 days Intervention

Title

Effect of tDCS over DLPFC on cognitive function.

Description

Cortical connectivity

Time Frame

Pre and Pos 20 days Intervention

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

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.

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wolnei Caumo, Dr.

Phone

+555199813977

wcaumo@hcpa.edu.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolnei Caumo, Dr

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90.450-120

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolnei Caumo, PhD

Phone

+5551 3359 6377

wcaumo@hcpa.edu.br

First Name & Middle Initial & Last Name & Degree

Wolnei Caumo, PhD

12. IPD Sharing Statement

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Montage of HTDCS in Psycho-cognitive Functions in FM

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