Neuromodulation and Its Therapeutic Potentiality in Different Populations

Study Overview
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Brief Summary
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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.

Official Title
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Transcranial Direct Current Stimulation and Its Therapeutic Potentiality in Different Populations

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M1<br>Transcranial direct current Stimulation in primary motor cortex | Device: Transcranial Direct Current Stimulation<br>* Non invasive brain modulation at a 2mA current during 20minutes<br>|
| Experimental: DLPFC<br>Transcranial direct current Stimulation in the dorsolateral pre-frontal cortex | Device: Transcranial Direct Current Stimulation<br>* Non invasive brain modulation at a 2mA current during 20minutes<br>|
| Sham Comparator: Sham<br>sham stimulation | Device: Transcranial Direct Current Stimulation<br>* Non invasive brain modulation at a 2mA current during 20minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain at 2 weeks | Diary of Pain | 1 week prior to treatment (Baseline) and 1 week during treatment | 
| Change from Baseline Pain at 5 weeks | Pressure Pain Threshold and Tolerance by an algometer | 1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment | 
| Change from Baseline Pain at 5 weeks | Visual Analogue Scale | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | Fibromyalgia Impact Questionnaire | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | 
| Mood | Beck Depression Inventory | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | 
| Anxiety | Hamilton Anxiety Scale | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | 
| Positive and negative affect | Positive and Negative Affect Schedule | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, tDCS