Neuromodulation and Its Therapeutic Potentiality in Different Populations
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, tDCS
Eligibility Criteria
Inclusion Criteria:
- Female gender aged from 18 to 65 year old, having a clinical diagnosis of Fibromyalgia given by a rheumatologist.
Exclusion Criteria:
- Non-regulated psychiatric disorders (bipolar, main depression, schizophrenia)
- Performing other types of treatment during the research
- Performing physical activities
Sites / Locations
- Hospital Universitário Onofre Lopes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
M1
DLPFC
Sham
Arm Description
Transcranial direct current Stimulation in primary motor cortex
Transcranial direct current Stimulation in the dorsolateral pre-frontal cortex
sham stimulation
Outcomes
Primary Outcome Measures
Change from Baseline Pain at 2 weeks
Diary of Pain
Change from Baseline Pain at 5 weeks
Pressure Pain Threshold and Tolerance by an algometer
Change from Baseline Pain at 5 weeks
Visual Analogue Scale
Secondary Outcome Measures
Functional Capacity
Fibromyalgia Impact Questionnaire
Mood
Beck Depression Inventory
Anxiety
Hamilton Anxiety Scale
Positive and negative affect
Positive and Negative Affect Schedule
Full Information
NCT ID
NCT03084094
First Posted
March 7, 2017
Last Updated
July 4, 2018
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT03084094
Brief Title
Neuromodulation and Its Therapeutic Potentiality in Different Populations
Official Title
Transcranial Direct Current Stimulation and Its Therapeutic Potentiality in Different Populations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One of the big challenges faced by researchers who act in rehabilitation science is the capacity to dispose integrative approaches for its utilization in clinical practice. The border profile of a physiotherapy researcher is to be in front of applied research amplification in experimental integrative approaches, involving the study of behavioral and physiological variables.
The rehabilitation process transcends the systems physiology and encompasses the cognitive behavioral feature of being adapted to the environment that surround us. It is now known by the scientific rehabilitation community the necessity for evidence based therapies and even more, therapeutic innovation. In both conditions, of health and illness, various options to use integrative approaches are today available in physiotherapy, including behavioral and physiological profiles of the individuals during physical activities, response to stress and in the field of chronic pain.
It is in the clinical routine of numerous rehabilitation centers the treatment of diseases that causes pain, being the leading figure in a physiotherapist work process. The innovative study of resources that can alter the pain state of this patients becomes primordial for routine clinical use, low cost and easy to apply. The therapeutic treatment for pain offered by a physiotherapist need new investigative options based in evidences from the association between the neuronal, behavioral and physiological responses where the brain is the central organ of this regulation. In this context, become increasingly more necessary the construction of investigative approaches in the purpose of reaching the clinical practice, in a reduced time lapse, once the great volume of information produced globally does not impact in short or medium term in new therapeutic recommendations.
Among the various chronic painful entities, it is presented the fibromyalgia (FM), painful diabetic polyneuropathy and primary dysmenorrhea because of its painful pathogenic complexity and its limited therapeutic against pain in rehabilitation process. The 3 painful entities presents the central nervous system as main participant of neurogenesis and maintenance of the painful state.
It is primordial importance that rehabilitation science improve methods of non invasive brain neuromodulation that allows, through excitation or inhibition of specific cortical areas in order to produce pain inhibition, providing a simple and low cost treatment to clinical routine. Technological advances and non invasive techniques to modulate brain function has been developed, among which transcranial direct current stimulation (tDCS) stands out. Basically, electrodes are placed in targeted brain regions that you want to stimulate or inhibit. Posteriorly, is applied a continuous electric current (0,4 - 2 mA) for a 3-20 minutes period, in order to modify cortical excitability. The stimulus of the anodic current increases cortical excitability whereas the stimulus of the cathodic current has an inhibitory effect.
Few are the research groups that address the issue of fibromyalgia, painful diabetic polyneuropathy and primary dysmenorrhea and the application of tDCS as research focus, being a border area for rehabilitation science and great potential in clinical use. Preliminary studies associates the use of tDCS with the decrease of painful state, however an approach of physical function and behavioral results needs greater investigation.
The purpose of the presented project is to present the tDCS as a new modality in physical rehabilitation for the patient with chronic pain of the 3 entities mentioned above. The study proposal is to present behavioral, social and physical results of tDCS application in this patients, suggesting a better quality of life and functionality of the individual.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, tDCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
M1
Arm Type
Experimental
Arm Description
Transcranial direct current Stimulation in primary motor cortex
Arm Title
DLPFC
Arm Type
Experimental
Arm Description
Transcranial direct current Stimulation in the dorsolateral pre-frontal cortex
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
sham stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Non invasive brain modulation at a 2mA current during 20minutes
Primary Outcome Measure Information:
Title
Change from Baseline Pain at 2 weeks
Description
Diary of Pain
Time Frame
1 week prior to treatment (Baseline) and 1 week during treatment
Title
Change from Baseline Pain at 5 weeks
Description
Pressure Pain Threshold and Tolerance by an algometer
Time Frame
1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment
Title
Change from Baseline Pain at 5 weeks
Description
Visual Analogue Scale
Time Frame
1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
Fibromyalgia Impact Questionnaire
Time Frame
1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment
Title
Mood
Description
Beck Depression Inventory
Time Frame
1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment
Title
Anxiety
Description
Hamilton Anxiety Scale
Time Frame
1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment
Title
Positive and negative affect
Description
Positive and Negative Affect Schedule
Time Frame
1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment
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 gender aged from 18 to 65 year old, having a clinical diagnosis of Fibromyalgia given by a rheumatologist.
Exclusion Criteria:
Non-regulated psychiatric disorders (bipolar, main depression, schizophrenia)
Performing other types of treatment during the research
Performing physical activities
Facility Information:
Facility Name
Hospital Universitário Onofre Lopes
City
Natal
State/Province
Rio Grande Do Norte
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Neuromodulation and Its Therapeutic Potentiality in Different Populations
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