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Trial record 37 of 104 for:    fibromyalgia | Open Studies | Interventional Studies

Effect of tDCS Related to Techniques in Cognitive Processing Attentional Retraining Fibromyalgia Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hospital de Clinicas de Porto Alegre
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02880917
First received: August 8, 2016
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
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 is 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 and expectation, in this study the investigators will test the hypothesis that the presence of pain will reduce the reaction time to visual stimuli related to pain/suffering, and this bias could be modified using transcranial direct current stimulation (tDCS).

Condition Intervention Phase
Fibromyalgia
Device: tDCS-Sham
Device: tDCS-Active
Device: Cognitive Retraining Active
Device: Cognitive Retraining Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Direct Current Stimulation (tDCS) Related to Techniques in Cognitive Processing Attentional Retraining Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Evaluate whether the ETCC associated with cognitive retraining technique is able to modulate attentional bias in fibromyalgia patients [ Time Frame: 8 days ]
    The investigator use the task dot -probe test to evaluate the attentional bias before and after treatment with TDCS and cognitive retraining.


Secondary Outcome Measures:
  • Pain [ Time Frame: 8 days ]
    Assessed with the Visual Analog Scale for 8 days

  • Scale Functional capacity--(Using The Brazilian Portuguese version of the Profile of Chronic Pain.) [ Time Frame: 2 days ]
    Measurement of functional capacity pre and pos application tDCS with scale functional capacity in chronic pain.

  • Test -Conditional pain modulation (CPM) [ Time Frame: 2 days-pre and pos application tDCS ]
    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.


Other Outcome Measures:
  • Maximal Heat Pain Tolerance [ Time Frame: 2 days ]
    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

  • Pain catastrophizing thoughts [ Time Frame: 2 days ]
    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.

  • Serum levels of Brain Derived Neurotrophic Factor (BDNF) [ Time Frame: 2 days ]
    Measurement of serum levels of BDNF pre and pos application tDCS

  • Beck Depression Inventory [ Time Frame: 2 days ]
    Measurement of Beck Depression Inventory pre and pos application tDCS

  • forward and backward digit span( WAIS) [ Time Frame: 2 days ]
    Measurement of forward and backward digit span pre and pos application tDCS

  • Pittsburgh sleep quality [ Time Frame: 2 days ]
    Measurement of Pittsburgh sleep quality pre and pos application tDCS

  • State-Trait Anxiety Inventory (STAI) test. [ Time Frame: 2 days ]
    Measurement of State-Trait Anxiety Inventory (STAI) test pre and pos application tDCS


Estimated Enrollment: 40
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive retraining + tDCs (Active)
tDCs active left dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive retraining Active (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.
Device: Cognitive Retraining Active
Use the task dot-probe test modified with the aim to train and focus attention not related to pain clues, diverting attention from subject to non-threatening stimuli. The Training will last for 8 days.
Sham Comparator: Cognitive retraining+ tDCs (Sham)
tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive retraining Sham (20min) at the same time
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: Cognitive Retraining Sham
The cognitive retraining (CT) sham using similar methodology to the active CT, however use figures without context with the research.
Cognitive retraining Active + tDCs-Sham
tDCs Sham -dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive retraining Active (20min) at the same time
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: Cognitive Retraining Active
Use the task dot-probe test modified with the aim to train and focus attention not related to pain clues, diverting attention from subject to non-threatening stimuli. The Training will last for 8 days.
Cognitive retraining -Sham +tDCs-Active
tDCs Active -dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive retraining Sham (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.
Device: Cognitive Retraining Sham
The cognitive retraining (CT) sham using similar methodology to the active CT, however use figures without context with the research.

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880917

Contacts
Contact: Wolnei Caumo, PhD wcaumo@hcpa.edu.br
Contact: Vinicius Santos, RN vini.enf@gmail.com

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90.450-120
Contact: Wolnei Caumo, PhD    +5551 3359 8083    wcaumo@hcpa.edu.br   
Principal Investigator: Wolnei Caumo, PhD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Wolnei Caumo, PhD Hospital de Clínicas de Porto Alegre
  More Information

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02880917     History of Changes
Other Study ID Numbers: 140369
Study First Received: August 8, 2016
Last Updated: August 23, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
Attention
Memory (short and long-term)
Conflict monitoring tasks
Verbal fluency

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2017