Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880917
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : December 26, 2017
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

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: tDCS-Sham Device: tDCS-Active Other: Cognitive training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Combined Treatment With tDCS and Cognitive Training on Attention and Working Memory in Patients With Fibromyalgia
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia Memory

Arm Intervention/treatment
Active Comparator: Cognitive training + tDCs-Active
tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (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.

Other: Cognitive training
. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.

Sham Comparator: Cognitive training+ tDCs-Sham
tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (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.

Other: Cognitive training
. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.




Primary Outcome Measures :
  1. Evaluate whether the tdcs associated with cognitive training technique or the combination of both interventions decrease memory deficits associated with Fibromyalgia. [ Time Frame: 8 days ]
    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.


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

  2. 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.

  3. 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:
  1. 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

  2. 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.

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

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

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

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

  7. Electroencephalogram/ event-related potential P300 [ Time Frame: 2 days ]
    Evaluate event-related potential (P300) pre and pos application tDCS

  8. Paced Auditory Serial Addiction Test(PASAT) [ Time Frame: 2 days ]
    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.

  9. Controlled Oral Word Association Test [ Time Frame: 2 days ]
    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.

  10. Forward and backward digit span [ Time Frame: 2 days ]
    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.

  11. Auditory Consonant Trigrams [ Time Frame: 2 days ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880917


Locations
Layout table for location information
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
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
Layout table for investigator information
Principal Investigator: Wolnei Caumo, PhD Hospital de Clínicas de Porto Alegre
Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02880917    
Other Study ID Numbers: 140369
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases