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Completed

NCT Number: NCT02408237

Transcranial Direct Current Stimulation Apparatus for Domiciliary Use

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fabiana Carvalho

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active tDCS Ambulatory

Device

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.

Other names: Transcranial Direct Current Stimulation

Sham tDCS Ambulatory

Device

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.

Other names: Transcranial Direct Current Stimulation

Active tDCS Home use

Device

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.

Other names: Transcranial Direct Current Stimulation

Sham tDCS Home use

Device

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.

Other names: Transcranial Direct Current Stimulation

Primary outcomes

  1. Cortical excitability on the transcranial magnetic stimulation (TMS)

    Time frame: 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 outcomes

  1. Serum levels of Brain Derived Neurotrophic Factor (BDNF)

    Time frame: 2 days

    Measurement of serum levels of BDNF pre and post application of tDCS.

  2. Pressure pain threshold

    Time frame: 2 days

    Measurement of pressure pain threshold pre and post application of tDCS.

  3. Heat pain threshold

    Time frame: 2 days

    Measurement of heat pain threshold pre and post application of tDCS, with quantitative sensory test (QST).

  4. Conditional pain modulation (CPM)

    Time frame: 2 days

    Assessment of conditional pain modulation pre and post application of tDCS, with cold and hot threshold.

  5. Number of participants with adverse events after use tDCS

    Time frame: 10 days

    Assessment of adverse events after use of Transcranial Direct Current Stimulation Apparatus for Domiciliary Use.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2015
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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