Transcranial Direct Current Stimulation Apparatus for Domiciliary Use

Not Applicable

Completed

• Conditions: Healthy Participants; Transcranial Direct Current Stimulation
• Interventions: Device: Active tDCS Home use; Device: Active tDCS Ambulatory; Device: Sham tDCS Ambulatory; Device: Sham tDCS Home use

• Registration Number: NCT02408237
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2017-03
• Study Start: 2017-03-28
• Primary Completion: 2017-08-31
• Study Completion: 2017-10-17
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tDCS home use & Sham	Active tDCS Home use	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.
tDCS Ambulatory & Sham	Active tDCS Ambulatory	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.
tDCS Ambulatory & Sham	Sham tDCS Ambulatory	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.
tDCS home use & Sham	Sham tDCS Home use	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.

Primary Outcome Measures

Name	Time	Method
Cortical excitability on the transcranial magnetic stimulation (TMS)	2 days	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fabiana Carvalho; 🇧🇷 Porto Alegre, Rio Grande Do SUL, Brazil