Clinical trial NCT02880917: Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia
Official title: Effects of Combined Treatment With tDCS and Cognitive Training on Attention and Working Memory in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Attention
Memory (short and long-term)
Conflict monitoring tasks
Verbal fluency
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2016-08-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate whether the tdcs associated with cognitive training technique or the combination of both interventions decrease memory deficits associated with Fibromyalgia.
timeFrame: 8 days
Secondary outcomes:
measure: Pain
timeFrame: 8 days
measure: Scale Functional capacity--(Using The Brazilian Portuguese version of the Profile of Chronic Pain.)
timeFrame: 2 days
measure: Test -Conditional pain modulation (CPM)
timeFrame: 2 days-pre and pos application tDCS
Other outcomes:
measure: Maximal Heat Pain Tolerance
timeFrame: 2 days
measure: Pain catastrophizing thoughts
timeFrame: 2 days
measure: Serum levels of Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 2 days
measure: Beck Depression Inventory
timeFrame: 2 days
measure: Pittsburgh sleep quality
timeFrame: 2 days
measure: State-Trait Anxiety Inventory (STAI) test.
timeFrame: 2 days
measure: Electroencephalogram/ event-related potential P300
timeFrame: 2 days
measure: Paced Auditory Serial Addiction Test(PASAT)
timeFrame: 2 days
measure: Controlled Oral Word Association Test
timeFrame: 2 days
measure: Forward and backward digit span
timeFrame: 2 days
measure: Auditory Consonant Trigrams
timeFrame: 2 days
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Wolnei Caumo, PhD
role: PRINCIPAL_INVESTIGATOR
References: