NCT02880917

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-10
• Completion: 2017-07-10
• First posted: 2016-08-26
• Last updated: 2017-12-26

Locations

1 site across 1 country: Brazil