Clinical trial NCT02408237: Transcranial Direct Current Stimulation Apparatus for Domiciliary Use
Official title: Development of Apparatus of Transcranial Direct Current Stimulation (tDCS) for Domiciliary Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Healthy Participants
Keywords: Transcranial direct current stimulation (tDCS)
tDCS for domiciliary use
Healthy Participants
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cortical excitability on the transcranial magnetic stimulation (TMS)
timeFrame: 2 days
Secondary outcomes:
measure: Serum levels of Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 2 days
measure: Pressure pain threshold
timeFrame: 2 days
measure: Heat pain threshold
timeFrame: 2 days
measure: Conditional pain modulation (CPM)
timeFrame: 2 days
measure: Number of participants with adverse events after use tDCS
timeFrame: 10 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Fabiana Carvalho
state: Rio Grande Do SUL
Study officials:
affiliation: +55513359808
name: Wolnei Caumo, PhD
role: STUDY_DIRECTOR
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