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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS Ambulatory & Sham | Active Comparator | 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. |
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| tDCS home use & Sham | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolnei Caumo, PhD | +55513359808 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabiana Carvalho | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21343407 | Background | Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614. | |
| 11723286 | Background | Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899. |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| 12949224 | Background | Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29. |
| 23146197 | Background | Martin DM, Alonzo A, Ho KA, Player M, Mitchell PB, Sachdev P, Loo CK. Continuation transcranial direct current stimulation for the prevention of relapse in major depression. J Affect Disord. 2013 Jan 25;144(3):274-8. doi: 10.1016/j.jad.2012.10.012. Epub 2012 Nov 10. |
| 23625554 | Background | Valiengo L, Bensenor IM, Goulart AC, de Oliveira JF, Zanao TA, Boggio PS, Lotufo PA, Fregni F, Brunoni AR. The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. Depress Anxiety. 2013 Jul;30(7):646-53. doi: 10.1002/da.22079. Epub 2013 Apr 26. |
| 21654618 | Background | DaSilva AF, Volz MS, Bikson M, Fregni F. Electrode positioning and montage in transcranial direct current stimulation. J Vis Exp. 2011 May 23;(51):2744. doi: 10.3791/2744. |
| 15753425 | Background | Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9. |
| 20633386 | Background | Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1. |
| 12686266 | Background | Priori A. Brain polarization in humans: a reappraisal of an old tool for prolonged non-invasive modulation of brain excitability. Clin Neurophysiol. 2003 Apr;114(4):589-95. doi: 10.1016/s1388-2457(02)00437-6. |
| 10990547 | Background | Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x. |
| 16045502 | Background | Lang N, Siebner HR, Ward NS, Lee L, Nitsche MA, Paulus W, Rothwell JC, Lemon RN, Frackowiak RS. How does transcranial DC stimulation of the primary motor cortex alter regional neuronal activity in the human brain? Eur J Neurosci. 2005 Jul;22(2):495-504. doi: 10.1111/j.1460-9568.2005.04233.x. |
| 23293607 | Background | Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012. |
| 10534598 | Background | Garcia-Larrea L, Peyron R, Mertens P, Gregoire MC, Lavenne F, Le Bars D, Convers P, Mauguiere F, Sindou M, Laurent B. Electrical stimulation of motor cortex for pain control: a combined PET-scan and electrophysiological study. Pain. 1999 Nov;83(2):259-73. doi: 10.1016/s0304-3959(99)00114-1. |
| 16564618 | Background | Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27. |
| 17133529 | Background | Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195. |
| 17903664 | Background | Silva G, Miksad R, Freedman SD, Pascual-Leone A, Jain S, Gomes DL, Amancio EJ, Boggio PS, Correa CF, Fregni F. Treatment of cancer pain with noninvasive brain stimulation. J Pain Symptom Manage. 2007 Oct;34(4):342-5. doi: 10.1016/j.jpainsymman.2007.06.002. No abstract available. |
| 17239806 | Background | Fregni F, Freedman S, Pascual-Leone A. Recent advances in the treatment of chronic pain with non-invasive brain stimulation techniques. Lancet Neurol. 2007 Feb;6(2):188-91. doi: 10.1016/S1474-4422(07)70032-7. |
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| 19403329 | Background | Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28. |
| 19394269 | Background | Bikson M, Datta A, Elwassif M. Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol. 2009 Jun;120(6):1033-4. doi: 10.1016/j.clinph.2009.03.018. Epub 2009 Apr 24. No abstract available. |
| 20488204 | Background | Minhas P, Bansal V, Patel J, Ho JS, Diaz J, Datta A, Bikson M. Electrodes for high-definition transcutaneous DC stimulation for applications in drug delivery and electrotherapy, including tDCS. J Neurosci Methods. 2010 Jul 15;190(2):188-97. doi: 10.1016/j.jneumeth.2010.05.007. Epub 2010 May 19. |
| 16291301 | Background | Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. doi: 10.1016/j.ejpain.2005.02.003. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |