Transcranial Direct Current Stimulation Apparatus for Domiciliary Use

Study Overview
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Brief Summary
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Neuromodulation is characterized as a technique whose principle neurostimulation to produce inhibition or cortical arousal. The tDCS (transcranial direct current stimulation) is a noninvasive brain stimulation method used to modulate cortical excitability using low intensity direct current (1-2mA) directed to the scalp via cathodes and anodes electrodes; the current reaches the cortex, producing hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique that can alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, acute mania, bipolar affective disorder panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after-stroke and pain syndromes such as neuropathic pain, migraine, pancreatitis chronic pain and fibromyalgia. It is low-cost technique, with virtually no side effects and carries the therapeutic effect by neuromodulatory pathways by distinct pathways activated by the drugs. In this scenario falls within the importance of developing devices for home use, inexpensive, and easy to use so as to maintain the benefits observed in previous studies. The tDCS is presented as a non-pharmacological option that may be offered in this context in society. It is noteworthy that, if the benefit is demonstrated, the impact will be of great importance to patients and to society, since these are focal techniques and low cost. Because they have no focal adverse effects of conventional drug treatments. Additionally, can be constituted as technical additive to pharmacotherapy in so much pain as in the treatment of other neuropsychiatric disorders. Therefore, further studies should be encouraged to increase knowledge of their effects and mechanisms involved. If the effectiveness of this method for home use is confirmed, the therapeutic impact will undoubtedly be of great importance. However, to make this project come true, the investigators depend on support for the development and validation of tDCS device for home use, so allowing the qualified knowledge can be applied to the clinical setting, as well as advance the development of this area of neuroscience in Brazil. Therefore, the aim of this study is to develop tDCS device for home use.

Official Title
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Development of Apparatus of Transcranial Direct Current Stimulation (tDCS) for Domiciliary Use

Conditions
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Transcranial Direct Current Stimulation, Healthy Participants

Intervention / Treatment
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* Device: Active tDCS Ambulatory
* Device: Sham tDCS Ambulatory
* Device: Active tDCS Home use
* Device: Sham tDCS Home use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, aged between 18 and 40 years. Higher education (college graduates in progress or completed). Exclusion Criteria: Subject left-handed. History of neurological disease. History of endocrine disease. History of psychiatric disorder. History of sleep disorders (apnea, hypersomnia, insomnia, sleepwalking ...). Chronic pain. Chronic inflammatory and oncological diseases. Systemic arterial hypertension; ischemic heart disease. Kidney and liver failure. Regular use of steroids and non-steroids anti inflammatory, opioids and non-opioids, psychotropics, anticonvulsants, alpha and beta-blockers. Regular use of drugs, alcohol and tobacco. History of brain surgery, tumor, stroke or intracranial implantation of metal (or not implemented). Subjects who do not understand Portuguese. Body mass index greater than 29.9.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS Ambulatory & Sham<br>Active tDCS Ambulatory: 1 mA of current of active tDCS applied for 20 minutes, single session of stimulation. Sham tDCS Ambulatory: applied for 20 minutes, single session of stimulation. | Device: Active tDCS Ambulatory<br>* Procedure begins with the placement of an anode electrode placed on the primary motor cortex (cortex contralateral to the dominant) and the cathode is placed on the contralateral supraorbital region. It is used 1mA direct current transcranial stimulation applied for 20 minutes. Will be held a single session of stimulation. The total time, with initial assessment, tDCS session and final evaluation will be approximately 4 hours.<br>* Other names: Transcranial Direct Current Stimulation;Device: Sham tDCS Ambulatory<br>* In sham group, we follow the same procedure and time as the active tDCS ambulatory protocol, but the device will be in the mode sham (inactive). The current is only applied for 30 seconds, so subjects feel a sense of the initial stimulation, but not the remainder receive current. In this group one session will also be held. The total time, with initial assessment, tDCS session and final evaluation will be approximately 4 hours.<br>* Other names: Transcranial Direct Current Stimulation;|
| Active Comparator: tDCS home use & Sham<br>Active tDCS home use: 11 active tDCS sessions: single session in the hospital and the remaining 10 in the subject's home, with duration of each active tDCS session of 20 min. Sham tDCS home use: 11 sessions of tDCS: single session in the hospital and the remaining 10 in the subject's home, with duration of each sham tDCS session of 20 min. | Device: Active tDCS Home use<br>* The procedure and stimulation time is exactly the same that Active tDCS - ambulatory use, but will use the apparatus for domestic use. Will be explained to the participant as placement of the cap and the device management. This group will be made 11 sessions of tDCS, the first held in the Hospital, with supervision of the researcher. The remaining 10 will be held in the participant's home. The total time of the first meeting, with initial assessment, tDCS session and final evaluation will be around 4 hours. The time of last evaluation is approximately 1 hour.<br>* Other names: Transcranial Direct Current Stimulation;Device: Sham tDCS Home use<br>* The procedure and stimulation time is exactly the same that Active tDCS - ambulatory use, but will use the apparatus for domestic use. In sham group, we follow the same procedure and time as the active tDCS protocol, but the device will be in the sham mode (inactive). The total time of the first meeting, with initial assessment, tDCS session and final evaluation will be around 4 hours. The time of last evaluation is approximately 1 hour.<br>* Other names: Transcranial Direct Current Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical excitability on the transcranial magnetic stimulation (TMS) | Evaluation of the variation in cortical excitability parameters pre and post application of tDCS: Motor evoked potential (MEP); Motor threshold (MT); intracortical facilitation, intracortical inhibition, silent period (SP). | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of Brain Derived Neurotrophic Factor (BDNF) | Measurement of serum levels of BDNF pre and post application of tDCS. | 2 days | 
| Pressure pain threshold | Measurement of pressure pain threshold pre and post application of tDCS. | 2 days | 
| Heat pain threshold | Measurement of heat pain threshold pre and post application of tDCS, with quantitative sensory test (QST). | 2 days | 
| Conditional pain modulation (CPM) | Assessment of conditional pain modulation pre and post application of tDCS, with cold and hot threshold. | 2 days | 
| Number of participants with adverse events after use tDCS | Assessment of adverse events after use of Transcranial Direct Current Stimulation Apparatus for Domiciliary Use. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial direct current stimulation (tDCS), tDCS for domiciliary use, Healthy Participants