tRNS Combined to Cognitive Training in Children With Dyscalculia
NCT ID: NCT04242680
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
102 participants
INTERVENTIONAL
2019-09-02
2024-05-05
Brief Summary
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Therefore, the investigators hypothesized that active tRNS over DLPFC or PPC combined to cognitive training will boost math and math-related skills in children and adolescents with DD, modulating theta/beta ratio around stimulated cerebral network. On the contrary, sham tRNS (placebo) over DLPFC or PPC combined to cognitive training will not have significant effect in improving math skills. Further, both active and sham tRNS combined to cognitive training will be safe and well tolerated.
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Detailed Description
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A group of children and adolescents with DD will be selected and randomly assigned to three different conditions: 1. tRNS over bilateral DLPFC + cognitive training (Brainstim DLPFC); 2. tRNS over bilateral PPC (Brainstim PPC) + cognitive training; 3. sham tRNS (bilateral DLPFC/bilateral PPC; Brainstim Sham) + cognitive training.
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS, combined to a usual treatment can improve the outcome of individual with DD.
The protocol will allow the investigators to:
1. testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
2. examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
3. predicting training outcomes based on math-related skills;
4. testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
5. investigating the safety and tolerability of tRNS.
The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brainstim DLPFC
tRNS over bilateral DLPFC + cognitive training
Brainstim DLPFC
The active tRNS will be delivered to bilateral DLPFC for five consecutive days for two weeks for a total of ten days.
tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
The electrodes will be placed on the left and right DLPFC, F3 and F4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
Stimulation intensity will be set at 0.75 milliampere (mA) (100-500 Hz), the duration of stimulation will be 20 min.
Cognitive Training
A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min.
The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation).
Brainstim PPC
tRNS over bilateral PPC + cognitive training
Brainstim PPC
The active tRNS will be delivered to bilateral PPC for five consecutive days for two weeks for a total of ten days.
tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
The electrodes will be placed on the left and right PPC, P3 and P4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
Stimulation intensity will be set at 0.75mA (100-500 Hz), the duration of stimulation will be 20 min.
Cognitive Training
A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min.
The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation).
Brainstim Sham
Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training
Brainstim Sham
The same electrode placement will be used as in the stimulation conditions (Brainstim DLPFC or Brainstim PPC), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held five consecutive days for two weeks for a total of ten days.
Cognitive Training
A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min.
The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation).
Interventions
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Brainstim DLPFC
The active tRNS will be delivered to bilateral DLPFC for five consecutive days for two weeks for a total of ten days.
tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
The electrodes will be placed on the left and right DLPFC, F3 and F4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
Stimulation intensity will be set at 0.75 milliampere (mA) (100-500 Hz), the duration of stimulation will be 20 min.
Brainstim PPC
The active tRNS will be delivered to bilateral PPC for five consecutive days for two weeks for a total of ten days.
tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
The electrodes will be placed on the left and right PPC, P3 and P4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
Stimulation intensity will be set at 0.75mA (100-500 Hz), the duration of stimulation will be 20 min.
Brainstim Sham
The same electrode placement will be used as in the stimulation conditions (Brainstim DLPFC or Brainstim PPC), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held five consecutive days for two weeks for a total of ten days.
Cognitive Training
A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min.
The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IQ ≥ 85
Exclusion Criteria
* Having neurological diseases;
* Having Epilepsy o family history of epilepsy;
* Receiving a treatment for DD in the previous three months before the baseline screening;
8 Years
14 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Deny Menghini
Clinical Psychologist
Locations
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Bambino Gesù Hospital and Research Institute
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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APA (2013). Diagnostic and statistical manual of mental disorders: DSM 5. Washington, DC: American Psychiatric Association.
Baroody, AJ., Tiilikainen, SH. Two perspectives on addition development. In: Baroody AJ, Dowker A, editors. The development of arithmetic concepts and skills: The construction of adaptive expertise. Erlbaum; Mahwah, NJ: 2003. pp. 75-125.
Belacchi, C., Scalisi, T.G., Cannoni, E. e Cornoldi, C. (2008). Matrici Progressive di Raven Forma
Biancardi, A., Bachmann, C., Nicoletti, C. (2016) BDE 2 - Batteria discalculia evolutiva Test per la diagnosi dei disturbi dell'elaborazione numerica e del calcolo in età evolutiva - 8-13 anni.
Cornoldi, C., Colpo, G. (2012). Prove di Lettura MT per la Scuola Elementare-2, Firenze, Organizzazioni Speciali.
Lehto, J.E. et al. (2003). Dimensions of executive functioning: Evidence from children. British Journal of Developmental Psychology, 21, 59-80.
Sartori, G., Job, R., Tressoldi, PE. (2007). DDE-2. Batteria per la valutazione della dislessia e della disortografia evolutiva, Firenze, Organizzazioni Speciali.
Ambrus GG, Paulus W, Antal A. Cutaneous perception thresholds of electrical stimulation methods: comparison of tDCS and tRNS. Clin Neurophysiol. 2010 Nov;121(11):1908-14. doi: 10.1016/j.clinph.2010.04.020. Epub 2010 May 14.
Ansari D. Effects of development and enculturation on number representation in the brain. Nat Rev Neurosci. 2008 Apr;9(4):278-91. doi: 10.1038/nrn2334.
Arsalidou M, Taylor MJ. Is 2+2=4? Meta-analyses of brain areas needed for numbers and calculations. Neuroimage. 2011 Feb 1;54(3):2382-93. doi: 10.1016/j.neuroimage.2010.10.009. Epub 2010 Oct 12.
Butterworth B. Foundational numerical capacities and the origins of dyscalculia. Trends Cogn Sci. 2010 Dec;14(12):534-41. doi: 10.1016/j.tics.2010.09.007.
Butterworth B, Varma S, Laurillard D. Dyscalculia: from brain to education. Science. 2011 May 27;332(6033):1049-53. doi: 10.1126/science.1201536.
Cantlon JF, Brannon EM, Carter EJ, Pelphrey KA. Functional imaging of numerical processing in adults and 4-y-old children. PLoS Biol. 2006 May;4(5):e125. doi: 10.1371/journal.pbio.0040125. Epub 2006 Apr 11.
Cappelletti M, Gessaroli E, Hithersay R, Mitolo M, Didino D, Kanai R, Cohen Kadosh R, Walsh V. Transfer of cognitive training across magnitude dimensions achieved with concurrent brain stimulation of the parietal lobe. J Neurosci. 2013 Sep 11;33(37):14899-907. doi: 10.1523/JNEUROSCI.1692-13.2013.
Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.
Cohen Kadosh R, Cohen Kadosh K, Schuhmann T, Kaas A, Goebel R, Henik A, Sack AT. Virtual dyscalculia induced by parietal-lobe TMS impairs automatic magnitude processing. Curr Biol. 2007 Apr 17;17(8):689-93. doi: 10.1016/j.cub.2007.02.056. Epub 2007 Mar 22.
Cohen Kadosh R, Lammertyn J, Izard V. Are numbers special? An overview of chronometric, neuroimaging, developmental and comparative studies of magnitude representation. Prog Neurobiol. 2008 Feb;84(2):132-47. doi: 10.1016/j.pneurobio.2007.11.001. Epub 2007 Nov 19.
Collins A, Koechlin E. Reasoning, learning, and creativity: frontal lobe function and human decision-making. PLoS Biol. 2012;10(3):e1001293. doi: 10.1371/journal.pbio.1001293. Epub 2012 Mar 27.
Costanzo F, Menghini D, Caltagirone C, Oliveri M, Vicari S. High frequency rTMS over the left parietal lobule increases non-word reading accuracy. Neuropsychologia. 2012 Sep;50(11):2645-51. doi: 10.1016/j.neuropsychologia.2012.07.017. Epub 2012 Jul 20.
Costanzo F, Menghini D, Caltagirone C, Oliveri M, Vicari S. How to improve reading skills in dyslexics: the effect of high frequency rTMS. Neuropsychologia. 2013 Dec;51(14):2953-9. doi: 10.1016/j.neuropsychologia.2013.10.018. Epub 2013 Oct 31.
Costanzo F, Rossi S, Varuzza C, Varvara P, Vicari S, Menghini D. Long-lasting improvement following tDCS treatment combined with a training for reading in children and adolescents with dyslexia. Neuropsychologia. 2019 Jul;130:38-43. doi: 10.1016/j.neuropsychologia.2018.03.016. Epub 2018 Mar 14.
Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Giacomo K, Vicari S, Menghini D. Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. Restor Neurol Neurosci. 2016;34(2):215-26. doi: 10.3233/RNN-150561.
Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Koch G, Vicari S, Menghini D. Reading changes in children and adolescents with dyslexia after transcranial direct current stimulation. Neuroreport. 2016 Mar 23;27(5):295-300. doi: 10.1097/WNR.0000000000000536.
Dehaene S. Origins of mathematical intuitions: the case of arithmetic. Ann N Y Acad Sci. 2009 Mar;1156:232-59. doi: 10.1111/j.1749-6632.2009.04469.x.
Dehaene S, Spelke E, Pinel P, Stanescu R, Tsivkin S. Sources of mathematical thinking: behavioral and brain-imaging evidence. Science. 1999 May 7;284(5416):970-4. doi: 10.1126/science.284.5416.970.
Delazer M, Domahs F, Bartha L, Brenneis C, Lochy A, Trieb T, Benke T. Learning complex arithmetic--an fMRI study. Brain Res Cogn Brain Res. 2003 Dec;18(1):76-88. doi: 10.1016/j.cogbrainres.2003.09.005.
Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
Fertonani A, Pirulli C, Miniussi C. Random noise stimulation improves neuroplasticity in perceptual learning. J Neurosci. 2011 Oct 26;31(43):15416-23. doi: 10.1523/JNEUROSCI.2002-11.2011.
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.
Hauser TU, Rotzer S, Grabner RH, Merillat S, Jancke L. Enhancing performance in numerical magnitude processing and mental arithmetic using transcranial Direct Current Stimulation (tDCS). Front Hum Neurosci. 2013 Jun 6;7:244. doi: 10.3389/fnhum.2013.00244. eCollection 2013.
Heth I, Lavidor M. Improved reading measures in adults with dyslexia following transcranial direct current stimulation treatment. Neuropsychologia. 2015 Apr;70:107-13. doi: 10.1016/j.neuropsychologia.2015.02.022. Epub 2015 Feb 19.
Hyde DC, Boas DA, Blair C, Carey S. Near-infrared spectroscopy shows right parietal specialization for number in pre-verbal infants. Neuroimage. 2010 Nov 1;53(2):647-52. doi: 10.1016/j.neuroimage.2010.06.030. Epub 2010 Jun 16.
Isaacs EB, Edmonds CJ, Lucas A, Gadian DG. Calculation difficulties in children of very low birthweight: a neural correlate. Brain. 2001 Sep;124(Pt 9):1701-7. doi: 10.1093/brain/124.9.1701.
Iuculano T, Cohen Kadosh R. Preliminary evidence for performance enhancement following parietal lobe stimulation in Developmental Dyscalculia. Front Hum Neurosci. 2014 Feb 7;8:38. doi: 10.3389/fnhum.2014.00038. eCollection 2014.
Kaufmann L, Mazzocco MM, Dowker A, von Aster M, Gobel SM, Grabner RH, Henik A, Jordan NC, Karmiloff-Smith AD, Kucian K, Rubinsten O, Szucs D, Shalev R, Nuerk HC. Dyscalculia from a developmental and differential perspective. Front Psychol. 2013 Aug 21;4:516. doi: 10.3389/fpsyg.2013.00516. eCollection 2013. No abstract available.
Kaufmann L, Wood G, Rubinsten O, Henik A. Meta-analyses of developmental fMRI studies investigating typical and atypical trajectories of number processing and calculation. Dev Neuropsychol. 2011;36(6):763-87. doi: 10.1080/87565641.2010.549884.
Korkman, M., Kirk, U., Kemp, S. (2011). NEPSY-II. Giunti, OS.
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.
Kucian K, Loenneker T, Dietrich T, Dosch M, Martin E, von Aster M. Impaired neural networks for approximate calculation in dyscalculic children: a functional MRI study. Behav Brain Funct. 2006 Sep 5;2:31. doi: 10.1186/1744-9081-2-31.
Looi CY, Duta M, Brem AK, Huber S, Nuerk HC, Cohen Kadosh R. Combining brain stimulation and video game to promote long-term transfer of learning and cognitive enhancement. Sci Rep. 2016 Feb 23;6:22003. doi: 10.1038/srep22003.
Looi CY, Lim J, Sella F, Lolliot S, Duta M, Avramenko AA, Cohen Kadosh R. Transcranial random noise stimulation and cognitive training to improve learning and cognition of the atypically developing brain: A pilot study. Sci Rep. 2017 Jul 5;7(1):4633. doi: 10.1038/s41598-017-04649-x.
Mattai A, Miller R, Weisinger B, Greenstein D, Bakalar J, Tossell J, David C, Wassermann EM, Rapoport J, Gogtay N. Tolerability of transcranial direct current stimulation in childhood-onset schizophrenia. Brain Stimul. 2011 Oct;4(4):275-80. doi: 10.1016/j.brs.2011.01.001. Epub 2011 Feb 1.
Miniussi C, Rossini PM. Transcranial magnetic stimulation in cognitive rehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):579-601. doi: 10.1080/09602011.2011.562689. Epub 2011 Jun 24.
Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.
Pasqualotto A. Transcranial random noise stimulation benefits arithmetic skills. Neurobiol Learn Mem. 2016 Sep;133:7-12. doi: 10.1016/j.nlm.2016.05.004. Epub 2016 May 17.
Popescu T, Krause B, Terhune DB, Twose O, Page T, Humphreys G, Cohen Kadosh R. Transcranial random noise stimulation mitigates increased difficulty in an arithmetic learning task. Neuropsychologia. 2016 Jan 29;81:255-264. doi: 10.1016/j.neuropsychologia.2015.12.028. Epub 2015 Dec 28.
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.
Price GR, Holloway I, Rasanen P, Vesterinen M, Ansari D. Impaired parietal magnitude processing in developmental dyscalculia. Curr Biol. 2007 Dec 18;17(24):R1042-3. doi: 10.1016/j.cub.2007.10.013.
Rivera SM, Reiss AL, Eckert MA, Menon V. Developmental changes in mental arithmetic: evidence for increased functional specialization in the left inferior parietal cortex. Cereb Cortex. 2005 Nov;15(11):1779-90. doi: 10.1093/cercor/bhi055. Epub 2005 Feb 16.
Rotzer S, Kucian K, Martin E, von Aster M, Klaver P, Loenneker T. Optimized voxel-based morphometry in children with developmental dyscalculia. Neuroimage. 2008 Jan 1;39(1):417-22. doi: 10.1016/j.neuroimage.2007.08.045. Epub 2007 Sep 7.
Rubio-Morell B, Rotenberg A, Hernandez-Exposito S, Pascual-Leone A. [The use of noninvasive brain stimulation in childhood psychiatric disorders: new diagnostic and therapeutic opportunities and challenges]. Rev Neurol. 2011 Aug 16;53(4):209-25. Spanish.
Snowball A, Tachtsidis I, Popescu T, Thompson J, Delazer M, Zamarian L, Zhu T, Cohen Kadosh R. Long-term enhancement of brain function and cognition using cognitive training and brain stimulation. Curr Biol. 2013 Jun 3;23(11):987-92. doi: 10.1016/j.cub.2013.04.045. Epub 2013 May 16.
Stanescu-Cosson R, Pinel P, van De Moortele PF, Le Bihan D, Cohen L, Dehaene S. Understanding dissociations in dyscalculia: a brain imaging study of the impact of number size on the cerebral networks for exact and approximate calculation. Brain. 2000 Nov;123 ( Pt 11):2240-55. doi: 10.1093/brain/123.11.2240.
Terney D, Chaieb L, Moliadze V, Antal A, Paulus W. Increasing human brain excitability by transcranial high-frequency random noise stimulation. J Neurosci. 2008 Dec 24;28(52):14147-55. doi: 10.1523/JNEUROSCI.4248-08.2008.
Turkeltaub PE, Benson J, Hamilton RH, Datta A, Bikson M, Coslett HB. Left lateralizing transcranial direct current stimulation improves reading efficiency. Brain Stimul. 2012 Jul;5(3):201-207. doi: 10.1016/j.brs.2011.04.002. Epub 2011 May 5.
Other Identifiers
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1547_OPBG_2018
Identifier Type: -
Identifier Source: org_study_id
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