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

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: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: tDCS-Active; Other: Cognitive training; Device: tDCS-Sham

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

Outcome Measure	Measure Description	Time Frame
Pain	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.)	Measurement of functional capacity pre and pos application tDCS with scale functional capacity in chronic pain.	2 days
Test -Conditional pain modulation (CPM)	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

Outcome Measure	Measure Description	Time Frame
Maximal Heat Pain Tolerance	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	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)	Measurement of serum levels of BDNF pre and pos application tDCS	2 days
Beck Depression Inventory	Measurement of Beck Depression Inventory pre and pos application tDCS	2 days
Pittsburgh sleep quality	Measurement of Pittsburgh sleep quality pre and pos application tDCS	2 days
State-Trait Anxiety Inventory (STAI) test.	Measurement of State-Trait Anxiety Inventory (STAI) test pre and pos application tDCS	2 days
Electroencephalogram/ event-related potential P300	Evaluate event-related potential (P300) pre and pos application tDCS	2 days
Paced Auditory Serial Addiction Test(PASAT)	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	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	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	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

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: 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: Principal Investigator: Wolnei Caumo, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Attention; Memory (short and long-term); Conflict monitoring tasks; Verbal fluency
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 140369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided