Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
tDCS-Sham
tDCS-Active
Cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Attention, Memory (short and long-term), Conflict monitoring tasks, Verbal fluency
Eligibility 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).
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Cognitive training + tDCs-Active
Cognitive training+ tDCs-Sham
Arm Description
tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (20min) at the same time.
tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (20min) at the same time.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain
Assessed with the Visual Analog Scale for 8 days
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.
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.
Full Information
NCT ID
NCT02880917
First Posted
August 8, 2016
Last Updated
December 21, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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
1. Study Identification
Unique Protocol Identification Number
NCT02880917
Brief Title
Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia
Official Title
Effects of Combined Treatment With tDCS and Cognitive Training on Attention and Working Memory in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Attention, Memory (short and long-term), Conflict monitoring tasks, Verbal fluency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training + tDCs-Active
Arm Type
Active Comparator
Arm Description
tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (20min) at the same time.
Arm Title
Cognitive training+ tDCs-Sham
Arm Type
Sham Comparator
Arm Description
tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (20min) at the same time.
Intervention Type
Device
Intervention Name(s)
tDCS-Sham
Intervention Description
Sham tDCS will involve an identical electrode montage, with stimulation ceasing after a 30-second ramp-up period to provide equivalent scalp sensation.
Intervention Type
Device
Intervention Name(s)
tDCS-Active
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive training
Intervention Description
. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.
Primary Outcome Measure Information:
Title
Evaluate whether the tdcs associated with cognitive training technique or the combination of both interventions decrease memory deficits associated with Fibromyalgia.
Description
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.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Pain
Description
Assessed with the Visual Analog Scale for 8 days
Time Frame
8 days
Title
Scale Functional capacity--(Using The Brazilian Portuguese version of the Profile of Chronic Pain.)
Description
Measurement of functional capacity pre and pos application tDCS with scale functional capacity in chronic pain.
Time Frame
2 days
Title
Test -Conditional pain modulation (CPM)
Description
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.
Time Frame
2 days-pre and pos application tDCS
Other Pre-specified Outcome Measures:
Title
Maximal Heat Pain Tolerance
Description
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
Time Frame
2 days
Title
Pain catastrophizing thoughts
Description
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.
Time Frame
2 days
Title
Serum levels of Brain Derived Neurotrophic Factor (BDNF)
Description
Measurement of serum levels of BDNF pre and pos application tDCS
Time Frame
2 days
Title
Beck Depression Inventory
Description
Measurement of Beck Depression Inventory pre and pos application tDCS
Time Frame
2 days
Title
Pittsburgh sleep quality
Description
Measurement of Pittsburgh sleep quality pre and pos application tDCS
Time Frame
2 days
Title
State-Trait Anxiety Inventory (STAI) test.
Description
Measurement of State-Trait Anxiety Inventory (STAI) test pre and pos application tDCS
Time Frame
2 days
Title
Electroencephalogram/ event-related potential P300
Description
Evaluate event-related potential (P300) pre and pos application tDCS
Time Frame
2 days
Title
Paced Auditory Serial Addiction Test(PASAT)
Description
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.
Time Frame
2 days
Title
Controlled Oral Word Association Test
Description
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.
Time Frame
2 days
Title
Forward and backward digit span
Description
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.
Time Frame
2 days
Title
Auditory Consonant Trigrams
Description
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.
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.450-120
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia
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