Transcranial Direct Current Stimulation on Inhibitory Control in Addictions.

NCT05350033 | Unknown

• 1 other identifier: TESADIC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The research in neuroscience of the last 20 years is defined, in addition to continuing to advance in the field of behavioral and pharmacological therapy, by the birth and development of a new therapeutic category, called neuromodulation. Neuromodulation offers the possibility of producing changes in the Nervous System (SN) and therefore, in behavior, in addition to lasting over time. One of the most used non-invasive neuromodulation techniques is transcranial direct current stimulation (tDCS). The benefits of tDCS are promising and varied, so it is a potential neurorehabilitation tool, which has also shown its greatest effectiveness when accompanied by complementary rehabilitation treatment. The present study focuses on the effect of tDCS on addiction. Specifically, there is a great problem with the high rates of relapse presented by those individuals who try to abandon addictive behavior. Therefore, the maintenance of the abstinence period is the central theme of addiction research and the main challenge of rehabilitation at present. For that aim, the intervention will be carried out in a sample in the intermediate phase (internal) in the NOESSO (No EstáS Sólo) therapeutic community (Almería, Spain), between day 15 after arrival and the first day to leave on leave (day 45-60). The research will be made up of a previous period of selection and collection of data related to addiction, together with two phases or moments of correlative intervention and evaluation. Users will receive a bilateral (F3/F4) and repeated stimulation of 2 mA intensity for 20 min each, that is, every 24h for 5 consecutive days in each phase. Through this procedure, the aim is to seek to increase adherence to treatment in the early intervention phase and decrease the dropout rate due to the enhancement of inhibitory control. On the other hand, in the second phase, advanced intervention is sought to reduce craving, through an improvement in inhibitory and emotional control at the time of returning to the context of real consumption. In order to increase the knowledge about intra-individual differences in the effect of tDCS, researchers will compare the early intervention (Phase 1, at the begging of the rehabilitation process) with the advanced intervention (Phase 2, right before the first leave).

Conditions

Substance-Related Disorders

Keywords

substance abuse; transcraneal electrical stimulation; tDCS; inhibitory control; drug craving; treatment adherence

Outcome Measures

Primary Outcomes (3)

• Dropouts phase 1: participants that abandon the treatment phase

  Number of participants that abandon the treatment phase before the first free weekend outside the center

  45-60 days

• Dropouts phase 2: participants that abandon the treatment after the first free weekend outside the center

  Number of participants that abandon the treatment after the first free weekend outside the center

  47-62 days

• Relapses:

  Number of relapses on drug comsuption during the first free weekend outside the center

  41-62 days

Secondary Outcomes (9)

• VAS - Craving

  Daily during the total ten days of intervention

• VAS - Fatigue

  For each interventional phase: first and fifth day

• STAI-E/R

  For each interventional phase: first and fifth day

• WHOQOL-BREF

  For each interventional phase: first and fifth day

• Beck BDI-BECK

  For each interventional phase: first and fifth day

Study Arms (4)

Active-Active

EXPERIMENTAL

Participants will receive active-tDCS stimulation (anode F4 / cathode F3) at 2 mA during 20 min in Phase 1 (5 sessions, intersession time-24h) and in Phase 2 (5 sessions, intersession time-24h).

Device: tDCS - tDCS

Active-Sham

EXPERIMENTAL

Participants will receive active-tDCS stimulation (anode F4 / cathode F3) at 2 mA during 20 min in Phase 1 (5 sessions, intersession time-24h), and sham-tDCS at 2 mA (active-stimulation lasting for 1 min) in Phase 2 (5 sessions, intersession time-24h).

Device: tDCS - Sham

Sham-Active

EXPERIMENTAL

Participants will receive sham-tDCS stimulation (anode F4 / cathode F3) at 2 mA (active-stimulation lasting for 1 min) in Phase 1 (5 sessions, intersession time-24h), and active-tDCS at 2 mA during 20 min in Phase 2 (5 sessions, intersession time-24h).

Device: Sham - tDCS

Sham-Sham

SHAM COMPARATOR

Participants will receive sham-tDCS stimulation (anode F4 / cathode F3) at 2 mA (active-stimulation lasting for 1 min) in Phase 1 (5 sessions, intersession time-24h), and sham-tDCS at 2 mA (active-stimulation lasting for 1 min) in Phase 2 (5 sessions, intersession time-24h).

Device: Sham - Sham

Interventions

tDCS - tDCS DEVICE

active-tDCS administered during 10 sessions, in Phase 1 and Phase 2

Active-Active

tDCS - Sham DEVICE

active-tDCS administered during 5 sessions, in Phase 1

Active-Sham

Sham - tDCS DEVICE

active-tDCS administered during 5 sessions, in Phase 2

Sham-Active

Sham - Sham DEVICE

sham-tDCS administered during 10 sessions, in Phase 1 and Phase 2

Sham-Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Substance abuse
• Under clinical treatment at the Noesso Addiction Rehabilitation Center La Quinta, Laujar de Andarax, Spain
• Participation approved by the clinical team
• Participation approved by the experimental team by means of the Göttingen screening questionnaire
• Signed informed consent
• At least 26 points in the Montreal Cognitive Assessment (MOCA) evaluation

You may not qualify if:

• Epilepsy or history of epilepsy (convulsions due compsumtion not included)
• Cardiopathy or cardiac electronic devices
• Skin reaction or high sensitivity to tDCS
• Head metallic implant
• Serious mental disease

Sponsors & Collaborators

• Universidad de Almeria: lead
• Junta de Andalucia: collaborator

Study Sites (1)

Psychobiology Lab

Almería, 04120, Spain

Location

Related Publications (66)

• Salling MC, Martinez D. Brain Stimulation in Addiction. Neuropsychopharmacology. 2016 Nov;41(12):2798-2809. doi: 10.1038/npp.2016.80. Epub 2016 May 31.

  PMID: 27240657 BACKGROUND

• Bajbouj M, Padberg F. A perfect match: noninvasive brain stimulation and psychotherapy. Eur Arch Psychiatry Clin Neurosci. 2014 Nov;264 Suppl 1:S27-33. doi: 10.1007/s00406-014-0540-6. Epub 2014 Sep 25.

  PMID: 25253645 BACKGROUND

• Page SJ, Cunningham DA, Plow E, Blazak B. It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S89-93. doi: 10.1016/j.apmr.2014.09.019.

  PMID: 25813373 BACKGROUND

• Hsu TY, Juan CH, Tseng P. Individual Differences and State-Dependent Responses in Transcranial Direct Current Stimulation. Front Hum Neurosci. 2016 Dec 21;10:643. doi: 10.3389/fnhum.2016.00643. eCollection 2016.

  PMID: 28066214 BACKGROUND

• Dubljevic V, Saigle V, Racine E. The rising tide of tDCS in the media and academic literature. Neuron. 2014 May 21;82(4):731-6. doi: 10.1016/j.neuron.2014.05.003.

  PMID: 24853934 BACKGROUND

• Lewis PM, Thomson RH, Rosenfeld JV, Fitzgerald PB. Brain Neuromodulation Techniques: A Review. Neuroscientist. 2016 Aug;22(4):406-21. doi: 10.1177/1073858416646707. Epub 2016 Apr 29.

  PMID: 27130839 BACKGROUND

• De Ridder D, Perera S, Vanneste S. State of the Art: Novel Applications for Cortical Stimulation. Neuromodulation. 2017 Apr;20(3):206-214. doi: 10.1111/ner.12593. Epub 2017 Mar 28.

  PMID: 28371170 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.

  PMID: 20633386 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.

  PMID: 10990547 BACKGROUND

• McKendrick R, Parasuraman R, Ayaz H. Wearable functional near infrared spectroscopy (fNIRS) and transcranial direct current stimulation (tDCS): expanding vistas for neurocognitive augmentation. Front Syst Neurosci. 2015 Mar 9;9:27. doi: 10.3389/fnsys.2015.00027. eCollection 2015.

  PMID: 25805976 BACKGROUND

• Zheng X, Schlaug G. Structural white matter changes in descending motor tracts correlate with improvements in motor impairment after undergoing a treatment course of tDCS and physical therapy. Front Hum Neurosci. 2015 Apr 30;9:229. doi: 10.3389/fnhum.2015.00229. eCollection 2015.

  PMID: 25983684 BACKGROUND

• Kim S, Stephenson MC, Morris PG, Jackson SR. tDCS-induced alterations in GABA concentration within primary motor cortex predict motor learning and motor memory: a 7 T magnetic resonance spectroscopy study. Neuroimage. 2014 Oct 1;99:237-43. doi: 10.1016/j.neuroimage.2014.05.070. Epub 2014 Jun 3.

  PMID: 24904994 BACKGROUND

• Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.

  PMID: 26381352 BACKGROUND

• Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.

  PMID: 17452283 BACKGROUND

• Minhas P, Datta A, Bikson M. Cutaneous perception during tDCS: role of electrode shape and sponge salinity. Clin Neurophysiol. 2011 Apr;122(4):637-8. doi: 10.1016/j.clinph.2010.09.023. Epub 2010 Nov 12. No abstract available.

  PMID: 21075048 BACKGROUND

• Moliadze V, Antal A, Paulus W. Electrode-distance dependent after-effects of transcranial direct and random noise stimulation with extracephalic reference electrodes. Clin Neurophysiol. 2010 Dec;121(12):2165-71. doi: 10.1016/j.clinph.2010.04.033. Epub 2010 Jun 15.

  PMID: 20554472 BACKGROUND

• Aree-uea B, Auvichayapat N, Janyacharoen T, Siritaratiwat W, Amatachaya A, Prasertnoo J, Tunkamnerdthai O, Thinkhamrop B, Jensen MP, Auvichayapat P. Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. J Med Assoc Thai. 2014 Sep;97(9):954-62.

  PMID: 25536713 BACKGROUND

• Cosmo C, Baptista AF, de Araujo AN, do Rosario RS, Miranda JG, Montoya P, de Sena EP. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder. PLoS One. 2015 Aug 12;10(8):e0135371. doi: 10.1371/journal.pone.0135371. eCollection 2015.

  PMID: 26267861 BACKGROUND

• Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.

  PMID: 25499471 BACKGROUND

• Floel A, Suttorp W, Kohl O, Kurten J, Lohmann H, Breitenstein C, Knecht S. Non-invasive brain stimulation improves object-location learning in the elderly. Neurobiol Aging. 2012 Aug;33(8):1682-9. doi: 10.1016/j.neurobiolaging.2011.05.007. Epub 2011 Jun 17.

  PMID: 21684040 BACKGROUND

• Rango M, Cogiamanian F, Marceglia S, Barberis B, Arighi A, Biondetti P, Priori A. Myoinositol content in the human brain is modified by transcranial direct current stimulation in a matter of minutes: a 1H-MRS study. Magn Reson Med. 2008 Oct;60(4):782-9. doi: 10.1002/mrm.21709.

  PMID: 18816828 BACKGROUND

• Vandermeeren Y, Jamart J, Ossemann M. Effect of tDCS with an extracephalic reference electrode on cardio-respiratory and autonomic functions. BMC Neurosci. 2010 Mar 16;11:38. doi: 10.1186/1471-2202-11-38.

  PMID: 20233439 BACKGROUND

• Tanaka S, Watanabe K. [Transcranial direct current stimulation--a new tool for human cognitive neuroscience]. Brain Nerve. 2009 Jan;61(1):53-64. Japanese.

  PMID: 19177807 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.

  PMID: 19394269 BACKGROUND

• Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

  PMID: 27372845 BACKGROUND

• Sanchez-Kuhn A, Perez-Fernandez C, Canovas R, Flores P, Sanchez-Santed F. Transcranial direct current stimulation as a motor neurorehabilitation tool: an empirical review. Biomed Eng Online. 2017 Aug 18;16(Suppl 1):76. doi: 10.1186/s12938-017-0361-8.

  PMID: 28830433 BACKGROUND

• Mehta S, McIntyre A, Guy S, Teasell RW, Loh E. Effectiveness of transcranial direct current stimulation for the management of neuropathic pain after spinal cord injury: a meta-analysis. Spinal Cord. 2015 Nov;53(11):780-5. doi: 10.1038/sc.2015.118. Epub 2015 Jul 21.

  PMID: 26193817 BACKGROUND

• Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.

  PMID: 19348793 BACKGROUND

• Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.

  PMID: 22581236 BACKGROUND

• Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.

  PMID: 26065432 BACKGROUND

• Sanchez-Kuhn A, Perez-Fernandez C, Moreno M, Flores P, Sanchez-Santed F. Differential Effects of Transcranial Direct Current Stimulation (tDCS) Depending on Previous Musical Training. Front Psychol. 2018 Sep 10;9:1465. doi: 10.3389/fpsyg.2018.01465. eCollection 2018.

  PMID: 30250439 BACKGROUND

• Costa TL, Lapenta OM, Boggio PS, Ventura DF. Transcranial direct current stimulation as a tool in the study of sensory-perceptual processing. Atten Percept Psychophys. 2015 Aug;77(6):1813-40. doi: 10.3758/s13414-015-0932-3.

  PMID: 26139152 BACKGROUND

• Javadi AH, Cheng P. Transcranial direct current stimulation (tDCS) enhances reconsolidation of long-term memory. Brain Stimul. 2013 Jul;6(4):668-74. doi: 10.1016/j.brs.2012.10.007. Epub 2012 Oct 31.

  PMID: 23137702 BACKGROUND

• Zhao S, Dou Z, Wei X, Li J, Dai M, Wang Y, Yang Q, He H. Task-concurrent anodal tDCS modulates bilateral plasticity in the human suprahyoid motor cortex. Front Hum Neurosci. 2015 Jun 24;9:370. doi: 10.3389/fnhum.2015.00370. eCollection 2015.

  PMID: 26157383 BACKGROUND

• Grecco LA, Duarte Nde A, de Mendonca ME, Pasini H, Lima VL, Franco RC, de Oliveira LV, de Carvalho Pde T, Correa JC, Collange NZ, Sampaio LM, Galli M, Fregni F, Oliveira CS. Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial. BMC Pediatr. 2013 Oct 11;13:168. doi: 10.1186/1471-2431-13-168.

  PMID: 24112817 BACKGROUND

• Volpato C, Piccione F, Cavinato M, Duzzi D, Schiff S, Foscolo L, Venneri A. Modulation of affective symptoms and resting state activity by brain stimulation in a treatment-resistant case of obsessive-compulsive disorder. Neurocase. 2013 Aug;19(4):360-70. doi: 10.1080/13554794.2012.667131. Epub 2012 May 4.

  PMID: 22554168 BACKGROUND

• Clarkson AN, Huang BS, Macisaac SE, Mody I, Carmichael ST. Reducing excessive GABA-mediated tonic inhibition promotes functional recovery after stroke. Nature. 2010 Nov 11;468(7321):305-9. doi: 10.1038/nature09511. Epub 2010 Nov 3.

  PMID: 21048709 BACKGROUND

• Filho PR, Vercelino R, Cioato SG, Medeiros LF, de Oliveira C, Scarabelot VL, Souza A, Rozisky JR, Quevedo Ada S, Adachi LN, Sanches PR, Fregni F, Caumo W, Torres IL. Transcranial direct current stimulation (tDCS) reverts behavioral alterations and brainstem BDNF level increase induced by neuropathic pain model: Long-lasting effect. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:44-51. doi: 10.1016/j.pnpbp.2015.06.016. Epub 2015 Jul 7.

  PMID: 26160698 BACKGROUND

• Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010 Apr 29;66(2):198-204. doi: 10.1016/j.neuron.2010.03.035.

  PMID: 20434997 BACKGROUND

• Serre F, Fatseas M, Denis C, Swendsen J, Auriacombe M. Predictors of craving and substance use among patients with alcohol, tobacco, cannabis or opiate addictions: Commonalities and specificities across substances. Addict Behav. 2018 Aug;83:123-129. doi: 10.1016/j.addbeh.2018.01.041. Epub 2018 Feb 2.

  PMID: 29428330 BACKGROUND

• Coles AS, Kozak K, George TP. A review of brain stimulation methods to treat substance use disorders. Am J Addict. 2018 Mar;27(2):71-91. doi: 10.1111/ajad.12674. Epub 2018 Feb 19.

  PMID: 29457674 BACKGROUND

• Gladwin TE, den Uyl TE, Fregni FF, Wiers RW. Enhancement of selective attention by tDCS: interaction with interference in a Sternberg task. Neurosci Lett. 2012 Mar 14;512(1):33-7. doi: 10.1016/j.neulet.2012.01.056. Epub 2012 Feb 2.

  PMID: 22327036 BACKGROUND

• Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

  PMID: 15999258 BACKGROUND

• Dockery CA, Hueckel-Weng R, Birbaumer N, Plewnia C. Enhancement of planning ability by transcranial direct current stimulation. J Neurosci. 2009 Jun 3;29(22):7271-7. doi: 10.1523/JNEUROSCI.0065-09.2009.

  PMID: 19494149 BACKGROUND

• Fecteau S, Pascual-Leone A, Zald DH, Liguori P, Theoret H, Boggio PS, Fregni F. Activation of prefrontal cortex by transcranial direct current stimulation reduces appetite for risk during ambiguous decision making. J Neurosci. 2007 Jun 6;27(23):6212-8. doi: 10.1523/JNEUROSCI.0314-07.2007.

  PMID: 17553993 BACKGROUND

• Goldstein RZ, Volkow ND. Dysfunction of the prefrontal cortex in addiction: neuroimaging findings and clinical implications. Nat Rev Neurosci. 2011 Oct 20;12(11):652-69. doi: 10.1038/nrn3119.

  PMID: 22011681 BACKGROUND

• Boggio PS, Sultani N, Fecteau S, Merabet L, Mecca T, Pascual-Leone A, Basaglia A, Fregni F. Prefrontal cortex modulation using transcranial DC stimulation reduces alcohol craving: a double-blind, sham-controlled study. Drug Alcohol Depend. 2008 Jan 1;92(1-3):55-60. doi: 10.1016/j.drugalcdep.2007.06.011. Epub 2007 Jul 19.

  PMID: 17640830 BACKGROUND

• den Uyl TE, Gladwin TE, Wiers RW. Transcranial direct current stimulation, implicit alcohol associations and craving. Biol Psychol. 2015 Feb;105:37-42. doi: 10.1016/j.biopsycho.2014.12.004. Epub 2014 Dec 23.

  PMID: 25541515 BACKGROUND

• Bari A, Robbins TW. Inhibition and impulsivity: behavioral and neural basis of response control. Prog Neurobiol. 2013 Sep;108:44-79. doi: 10.1016/j.pneurobio.2013.06.005. Epub 2013 Jul 13.

  PMID: 23856628 BACKGROUND

• Dalley JW, Everitt BJ, Robbins TW. Impulsivity, compulsivity, and top-down cognitive control. Neuron. 2011 Feb 24;69(4):680-94. doi: 10.1016/j.neuron.2011.01.020.

  PMID: 21338879 BACKGROUND

• Fineberg NA, Potenza MN, Chamberlain SR, Berlin HA, Menzies L, Bechara A, Sahakian BJ, Robbins TW, Bullmore ET, Hollander E. Probing compulsive and impulsive behaviors, from animal models to endophenotypes: a narrative review. Neuropsychopharmacology. 2010 Feb;35(3):591-604. doi: 10.1038/npp.2009.185. Epub 2009 Nov 25.

  PMID: 19940844 BACKGROUND

• Lawrence AJ, Luty J, Bogdan NA, Sahakian BJ, Clark L. Problem gamblers share deficits in impulsive decision-making with alcohol-dependent individuals. Addiction. 2009 Jun;104(6):1006-15. doi: 10.1111/j.1360-0443.2009.02533.x.

  PMID: 19466924 BACKGROUND

• Moreno M, Estevez AF, Zaldivar F, Montes JM, Gutierrez-Ferre VE, Esteban L, Sanchez-Santed F, Flores P. Impulsivity differences in recreational cannabis users and binge drinkers in a university population. Drug Alcohol Depend. 2012 Aug 1;124(3):355-62. doi: 10.1016/j.drugalcdep.2012.02.011. Epub 2012 Mar 15.

  PMID: 22425410 BACKGROUND

• Gilmore CS, Dickmann PJ, Nelson BG, Lamberty GJ, Lim KO. Transcranial Direct Current Stimulation (tDCS) paired with a decision-making task reduces risk-taking in a clinically impulsive sample. Brain Stimul. 2018 Mar-Apr;11(2):302-309. doi: 10.1016/j.brs.2017.11.011. Epub 2017 Nov 22.

  PMID: 29174303 BACKGROUND

• Shen B, Yin Y, Wang J, Zhou X, McClure SM, Li J. High-definition tDCS alters impulsivity in a baseline-dependent manner. Neuroimage. 2016 Dec;143:343-352. doi: 10.1016/j.neuroimage.2016.09.006. Epub 2016 Sep 6.

  PMID: 27608604 BACKGROUND

• Saba G, Moukheiber A, Pelissolo A. Transcranial cortical stimulation in the treatment of obsessive-compulsive disorders: efficacy studies. Curr Psychiatry Rep. 2015 May;17(5):36. doi: 10.1007/s11920-015-0571-3.

  PMID: 25825002 BACKGROUND

• Senco NM, Huang Y, D'Urso G, Parra LC, Bikson M, Mantovani A, Shavitt RG, Hoexter MQ, Miguel EC, Brunoni AR. Transcranial direct current stimulation in obsessive-compulsive disorder: emerging clinical evidence and considerations for optimal montage of electrodes. Expert Rev Med Devices. 2015 Jul;12(4):381-91. doi: 10.1586/17434440.2015.1037832. Epub 2015 May 17.

  PMID: 25982412 BACKGROUND

• Val-Laillet D, Aarts E, Weber B, Ferrari M, Quaresima V, Stoeckel LE, Alonso-Alonso M, Audette M, Malbert CH, Stice E. Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. Neuroimage Clin. 2015 Mar 24;8:1-31. doi: 10.1016/j.nicl.2015.03.016. eCollection 2015.

  PMID: 26110109 BACKGROUND

• Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

  PMID: 16427357 BACKGROUND

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.

  PMID: 1393159 BACKGROUND

• Bobes García J, G.-Portilla MP, Bascarán Fernández MT, Saiz Martínez PA, Bousoño García M. Banco de instrumentos básicos para la práctica de la psiquiatría clínica. Ars Médica, Barcelona. 2004.

  BACKGROUND

• Whisman MA, Richardson ED. Normative Data on the Beck Depression Inventory--Second Edition (BDI-II) in College Students. J Clin Psychol. 2015 Sep;71(9):898-907. doi: 10.1002/jclp.22188. Epub 2015 May 7.

  PMID: 25950150 BACKGROUND

• Stanford MS, Mathias CW, Dougherty DM, Lake SL, Anderson NE, Patton JH. Fifty years of the Barratt Impulsiveness Scale: An update and review. Personality and Individual Differences. 2009; 47(5): 385-395.

  BACKGROUND

• Hodgson RJ, Rachman S. Obsessional-compulsive complaints. Behav Res Ther. 1977;15(5):389-95. doi: 10.1016/0005-7967(77)90042-0. No abstract available.

  PMID: 612339 BACKGROUND

• Sanchez-Kuhn A, Leon JJ, Gongora K, Perez-Fernandez C, Sanchez-Santed F, Moreno M, Flores P. Go/No-Go task performance predicts differences in compulsivity but not in impulsivity personality traits. Psychiatry Res. 2017 Nov;257:270-275. doi: 10.1016/j.psychres.2017.07.064. Epub 2017 Jul 31.

  PMID: 28783574 BACKGROUND

• Hochman S, Henik A, Kalanthroff E. Stopping at a red light: Recruitment of inhibitory control by environmental cues. PLoS One. 2018 May 3;13(5):e0196199. doi: 10.1371/journal.pone.0196199. eCollection 2018.

  PMID: 29723204 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Treatment Adherence and Compliance

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Fernando Sánchez-Santed, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care providers communicate to the PI for participants' availability each week. PI assigns an anonymization code that serves to activate the stimulation device in active or sham-mode, blinded to investigators or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * Group 1: Active-stimulation in Phase 1 and Phase 2 * Group 2: Active-stimulation in Phase 1 and Sham-stimulation in Phase 2 * Group 3: Sham-stimulation in Phase 1 and Active-stimulation in Phase 2 * Group 4: Sham-stimulation in Phase 1 and Phase 2

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 27, 2022
• Study Start: April 5, 2021
• Primary Completion: July 15, 2022
• Study Completion: December 31, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available between six and twelve months after each potential publication
• Access Criteria: No restrictions will be applied

Locations

ES (1)