At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Development of Apparatus of Transcranial Direct Current Stimulation (tDCS) for Domiciliary Use
In Brief
A clinical study evaluating Active tDCS Ambulatory, Sham tDCS Ambulatory, and 2 other interventions for Transcranial Direct Current Stimulation and Healthy Participants. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.
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.