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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880917
• Other study ID #: 140369
• Status: Completed
• Phase: N/A
• First received: August 8, 2016
• Last updated: December 21, 2017
• Start date: November 2015
• Est. completion date: July 10, 2017

Study information

• Verified date: December 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Serum levels of Brain Derived Neurotrophic Factor (BDNF)	Measurement of serum levels of BDNF pre and pos application tDCS	2 days
Other	Beck Depression Inventory	Measurement of Beck Depression Inventory pre and pos application tDCS	2 days
Other	Pittsburgh sleep quality	Measurement of Pittsburgh sleep quality pre and pos application tDCS	2 days
Other	State-Trait Anxiety Inventory (STAI) test.	Measurement of State-Trait Anxiety Inventory (STAI) test pre and pos application tDCS	2 days
Other	Electroencephalogram/ event-related potential P300	Evaluate event-related potential (P300) pre and pos application tDCS	2 days
Other	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
Other	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
Other	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
Other	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
Primary	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	Pain	Assessed with the Visual Analog Scale for 8 days	8 days
Secondary	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
Secondary	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