Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia

December 21, 2017 updated by: Hospital de Clinicas de Porto Alegre

Effects of Combined Treatment With tDCS and Cognitive Training on Attention and Working Memory in Patients With Fibromyalgia

Chronic pain represents an important health problem responsible for decreases in quality of life, and is associated with great negative impact in society and economy. In many cases, its treatment does not reach therapeutic success causing health professionals and patients dissatisfaction. Chronic pain is also associated with somatization, hopelessness and catastrophizing thinking. These information processing includes sensorial, emotional and cognitive-appraisal thinking, which manifests the working of neural networks at cortical and sub-cortical levels. Attention and memory are a central aspect in the processing of pain modulation. Like in addictions (e.g. smoking, alcohol), chronic pain may debut with displacement in the focus of attention and alterations in the sensorial processing in the incentive-motivation tests. Considering that other studies have indicated that experimental and clinical pain is capable of modulating cognitive activities such as attention,memory and expectation, in this study the investigators will test whether cognitive training, tDCS, or the combination of both interventions decrease cognitive deficits associated with Fibromyalgia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Will be included women aged between 18 and 65 years, chronic pain fibromyalgia according to the criteria of the American College of Rheumatology, pain unresponsive to analgesics such as paracetamol, acetylsalicylic acid, ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and Codeine and give informed consent to participate after initial evaluation. Primary outcome is to Evaluate whether the tDCS associated with cognitive retraining technique is able to modulate attentional bias in fibromyalgia patients. Secondary outcomes are: compare the effect of active tDCS and sham in: Assessed with the Visual Analog Scale for 8 days, Functional capacity, Conditional pain modulation (CPM), Maximal Heat Pain tolerance,Catastrophic thinking,Serum levels of Brain Derived Neurotrophic Factor (BDNF), Beck Depression Inventory, forward and backward digit span( WAIS),Pittsburgh sleep quality and State-Trait Anxiety Inventory (STAI) test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients
  • literate
  • right-handed
  • 18 to 65 years of age
  • who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

Exclusion Criteria:

  • Pregnant women
  • Contraindications to tDCS
  • Metal implant in the brain
  • History of alcohol or drug abuse in the last six months
  • History of neurological disorders
  • Unexplained fainting
  • Self-reports of head injury or momentary loss of awareness
  • Neurosurgery.
  • Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cognitive training + tDCs-Active
tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (20min) at the same time.
Device: tDCS-Active
tDCS was delivered using the anode electrode positioned over the left dorsolateral prefrontal cortex (DLPFE) and the cathode electrode at supra orbital right region. The electrodes were placed into a 25-35 cm2 square sponge immersed in saline solution for better current conductivity. Current density used was 2 mA and electrodes attached to the scalp were sustained by rubber band.
Other: Cognitive training
. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.
Sham Comparator: Cognitive training+ tDCs-Sham
tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (20min) at the same time.
Other: Cognitive training
. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.
Device: tDCS-Sham
Sham tDCS will involve an identical electrode montage, with stimulation ceasing after a 30-second ramp-up period to provide equivalent scalp sensation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate whether the tdcs associated with cognitive training technique or the combination of both interventions decrease memory deficits associated with Fibromyalgia.
Time Frame: 8 days
I will use the rey auditory-verbal learning test(RAVLT) to evaluate the memory functions of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.
8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 8 days
Assessed with the Visual Analog Scale for 8 days
8 days
Scale Functional capacity--(Using The Brazilian Portuguese version of the Profile of Chronic Pain.)
Time Frame: 2 days
Measurement of functional capacity pre and pos application tDCS with scale functional capacity in chronic pain.
2 days
Test -Conditional pain modulation (CPM)
Time Frame: 2 days-pre and pos application tDCS
The protocol for heat pain threshold is repeated while the contralateral hand is placed on iced water. The pain due to heat and cold reported on a Visual Analog Scale are recorded.
2 days-pre and pos application tDCS

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal Heat Pain Tolerance
Time Frame: 2 days
Assessed using quantitative sensory testing. Briefly, the thermode placed in subjects forearm is heated until subject reports maximum tolerated pain. A maximal temperature of 52 Celsius has been previously programmed for the device to stop and cool down in order to avoid unintended injuries
2 days
Pain catastrophizing thoughts
Time Frame: 2 days
Measurement of catastrophic thinking pre and pos application tDCS with catastrophizing.The level of catastrophic thinking will be assessed by the Pain Catastrophizing Scale on Treatment scale.
2 days
Serum levels of Brain Derived Neurotrophic Factor (BDNF)
Time Frame: 2 days
Measurement of serum levels of BDNF pre and pos application tDCS
2 days
Beck Depression Inventory
Time Frame: 2 days
Measurement of Beck Depression Inventory pre and pos application tDCS
2 days
Pittsburgh sleep quality
Time Frame: 2 days
Measurement of Pittsburgh sleep quality pre and pos application tDCS
2 days
State-Trait Anxiety Inventory (STAI) test.
Time Frame: 2 days
Measurement of State-Trait Anxiety Inventory (STAI) test pre and pos application tDCS
2 days
Electroencephalogram/ event-related potential P300
Time Frame: 2 days
Evaluate event-related potential (P300) pre and pos application tDCS
2 days
Paced Auditory Serial Addiction Test(PASAT)
Time Frame: 2 days
I will use the Paced Auditory Serial Addiction Test to evaluate the memory functions of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.
2 days
Controlled Oral Word Association Test
Time Frame: 2 days
I will use the Controlled Oral Word Association Test to evaluate the verbal fluency of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.
2 days
Forward and backward digit span
Time Frame: 2 days
I will use the forward and backward digit span to evaluate the working memory of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.
2 days
Auditory Consonant Trigrams
Time Frame: 2 days
I will use the Auditory Consonant Trigrams to evaluate the working memory of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolnei Caumo, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 140369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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