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

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: tDCS-Sham; Device: tDCS-Active; Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT02880917

140369

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Cognitive training + tDCs-Active

Active Comparator group

Description:

tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (20min) at the same time.

Treatment:

Other: Cognitive training

Device: tDCS-Active

Cognitive training+ tDCs-Sham

Sham Comparator group

Description:

tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (20min) at the same time.

Treatment:

Device: tDCS-Sham

Other: Cognitive training