Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia

NCT05832060 | Unknown

• 1 other identifier: 2639_OPBG_2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD. The investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.

Conditions

Developmental Dyslexia

Keywords

Children; Adolescents; tRNS; transcranial random noise stimulation; tDCS; transcranial direct current stimulation; neurodevelopmental disorders; non-invasive brain stimulation; transcranial electrical stimulation; EEG; reading abilities

Outcome Measures

Primary Outcomes (1)

• Text reading accuracy (Experimental reading task)

  Change from baseline in text reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.

  during procedure

Secondary Outcomes (7)

• Text reading speed (Experimental reading task)

  during procedure

• Experimental reading task: high-frequency word reading accuracy

  during procedure

• Experimental reading task: high-frequency word reading speed

  during procedure

• Experimental reading task: low-frequency word reading accuracy

  during procedure

• Experimental reading task: low-frequency word reading speed

  during procedure

Study Arms (6)

tDCS, tRNS, Sham

EXPERIMENTAL

1. Active left anodal/right cathodal tDCS over TPC 2. Active tRNS over bilateral TPC 3. Sham tRNS or tDCS over bilateral TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

tDCS, Sham, tRNS

EXPERIMENTAL

1. Active left anodal/right cathodal tDCS over TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active tRNS over bilateral TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

tRNS, tDCS, Sham

EXPERIMENTAL

1. Active tRNS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Sham tRNS or tDCS over bilateral TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

tRNS, Sham, tDCS

EXPERIMENTAL

1. Active tRNS over bilateral TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

Sham, tDCS, tRNS

EXPERIMENTAL

1. Sham tRNS or tDCS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Active tRNS over bilateral TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

Sham, tRNS, tDCS

EXPERIMENTAL

1. Sham tRNS or tDCS over bilateral TPC 2. Active tRNS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC

Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

Interventions

Active tDCS DEVICE

Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.

Sham, tDCS, tRNS; Sham, tRNS, tDCS; tDCS, Sham, tRNS; tDCS, tRNS, Sham; tRNS, Sham, tDCS; tRNS, tDCS, Sham

Active tRNS DEVICE

Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.

Sham, tDCS, tRNS; Sham, tRNS, tDCS; tDCS, Sham, tRNS; tDCS, tRNS, Sham; tRNS, Sham, tDCS; tRNS, tDCS, Sham

Sham tRNS or tDCS DEVICE

Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.

Sham, tDCS, tRNS; Sham, tRNS, tDCS; tDCS, Sham, tRNS; tDCS, tRNS, Sham; tRNS, Sham, tDCS; tRNS, tDCS, Sham

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents with dyslexia (DSM-5, APA 2013)
• IQ ≥ 85

You may not qualify if:

• Having a comorbidity with an important medical conditions;
• Having neurological diseases;
• Having Epilepsy o family history of epilepsy;
• Receiving a treatment for dyslexia in the previous three months before the baseline screening.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Roma, 00165, Italy

Location

Related Publications (47)

• Shaywitz BA, Shaywitz SE, Pugh KR, Mencl WE, Fulbright RK, Skudlarski P, Constable RT, Marchione KE, Fletcher JM, Lyon GR, Gore JC. Disruption of posterior brain systems for reading in children with developmental dyslexia. Biol Psychiatry. 2002 Jul 15;52(2):101-10. doi: 10.1016/s0006-3223(02)01365-3.

  PMID: 12114001 RESULT

• Temple E, Deutsch GK, Poldrack RA, Miller SL, Tallal P, Merzenich MM, Gabrieli JD. Neural deficits in children with dyslexia ameliorated by behavioral remediation: evidence from functional MRI. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2860-5. doi: 10.1073/pnas.0030098100. Epub 2003 Feb 25.

  PMID: 12604786 RESULT

• Hoeft F, McCandliss BD, Black JM, Gantman A, Zakerani N, Hulme C, Lyytinen H, Whitfield-Gabrieli S, Glover GH, Reiss AL, Gabrieli JD. Neural systems predicting long-term outcome in dyslexia. Proc Natl Acad Sci U S A. 2011 Jan 4;108(1):361-6. doi: 10.1073/pnas.1008950108. Epub 2010 Dec 20.

  PMID: 21173250 RESULT

• Hoeft F, Hernandez A, McMillon G, Taylor-Hill H, Martindale JL, Meyler A, Keller TA, Siok WT, Deutsch GK, Just MA, Whitfield-Gabrieli S, Gabrieli JD. Neural basis of dyslexia: a comparison between dyslexic and nondyslexic children equated for reading ability. J Neurosci. 2006 Oct 18;26(42):10700-8. doi: 10.1523/JNEUROSCI.4931-05.2006.

  PMID: 17050709 RESULT

• Shaywitz SE, Shaywitz BA, Pugh KR, Fulbright RK, Constable RT, Mencl WE, Shankweiler DP, Liberman AM, Skudlarski P, Fletcher JM, Katz L, Marchione KE, Lacadie C, Gatenby C, Gore JC. Functional disruption in the organization of the brain for reading in dyslexia. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2636-41. doi: 10.1073/pnas.95.5.2636.

  PMID: 9482939 RESULT

• Bakker DJ. Treatment of developmental dyslexia: a review. Pediatr Rehabil. 2006 Jan-Mar;9(1):3-13. doi: 10.1080/13638490500065392.

  PMID: 16352500 RESULT

• Simos PG, Fletcher JM, Bergman E, Breier JI, Foorman BR, Castillo EM, Davis RN, Fitzgerald M, Papanicolaou AC. Dyslexia-specific brain activation profile becomes normal following successful remedial training. Neurology. 2002 Apr 23;58(8):1203-13. doi: 10.1212/wnl.58.8.1203.

  PMID: 11971088 RESULT

• Stuss DT. The future of cognitive neurorehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):755-68. doi: 10.1080/09602011.2011.605590. Epub 2011 Sep 27.

  PMID: 21950776 RESULT

• 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.

  PMID: 28680099 RESULT

• Nitsche MA, Schauenburg A, Lang N, Liebetanz D, Exner C, Paulus W, Tergau F. Facilitation of implicit motor learning by weak transcranial direct current stimulation of the primary motor cortex in the human. J Cogn Neurosci. 2003 May 15;15(4):619-26. doi: 10.1162/089892903321662994.

  PMID: 12803972 RESULT

• 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 RESULT

• Cattaneo Z, Pisoni A, Papagno C. Transcranial direct current stimulation over Broca's region improves phonemic and semantic fluency in healthy individuals. Neuroscience. 2011 Jun 2;183:64-70. doi: 10.1016/j.neuroscience.2011.03.058. Epub 2011 Apr 6.

  PMID: 21477637 RESULT

• Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.

  PMID: 19064743 RESULT

• Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

  PMID: 20395612 RESULT

• Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.

  PMID: 18096677 RESULT

• Schneider HD, Hopp JP. The use of the Bilingual Aphasia Test for assessment and transcranial direct current stimulation to modulate language acquisition in minimally verbal children with autism. Clin Linguist Phon. 2011 Jun;25(6-7):640-54. doi: 10.3109/02699206.2011.570852. Epub 2011 Jun 1.

  PMID: 21631313 RESULT

• Vines BW, Norton AC, Schlaug G. Non-invasive brain stimulation enhances the effects of melodic intonation therapy. Front Psychol. 2011 Sep 26;2:230. doi: 10.3389/fpsyg.2011.00230. eCollection 2011.

  PMID: 21980313 RESULT

• 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.

  PMID: 21462081 RESULT

• Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.

  PMID: 18525028 RESULT

• Rufener KS, Krauel K, Meyer M, Heinze HJ, Zaehle T. Transcranial electrical stimulation improves phoneme processing in developmental dyslexia. Brain Stimul. 2019 Jul-Aug;12(4):930-937. doi: 10.1016/j.brs.2019.02.007. Epub 2019 Feb 13.

  PMID: 30826318 RESULT

• 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.

  PMID: 25701796 RESULT

• 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.

  PMID: 26890096 RESULT

• 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 RESULT

• 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.

  PMID: 16045502 RESULT

• Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.

  PMID: 21068427 RESULT

• Schlaug G, Marchina S, Norton A. From Singing to Speaking: Why Singing May Lead to Recovery of Expressive Language Function in Patients with Broca's Aphasia. Music Percept. 2008 Apr 1;25(4):315-323. doi: 10.1525/MP.2008.25.4.315.

  PMID: 21197418 RESULT

• 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.

  PMID: 21780073 RESULT

• Jancke L, Cheetham M, Baumgartner T. Virtual reality and the role of the prefrontal cortex in adults and children. Front Neurosci. 2009 May 1;3(1):52-9. doi: 10.3389/neuro.01.006.2009. eCollection 2009 May.

  PMID: 19753097 RESULT

• 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.

  PMID: 22032743 RESULT

• Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

  PMID: 21320389 RESULT

• 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.

  PMID: 19109497 RESULT

• 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.

  PMID: 24027289 RESULT

• 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.

  PMID: 24064065 RESULT

• 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.

  PMID: 22820638 RESULT

• 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.

  PMID: 29550525 RESULT

• 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.

  PMID: 26848997 RESULT

• 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.

  PMID: 22031888 RESULT

• 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.

  PMID: 23684971 RESULT

• 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.

  PMID: 22305346 RESULT

• Linkersdorfer J, Lonnemann J, Lindberg S, Hasselhorn M, Fiebach CJ. Grey matter alterations co-localize with functional abnormalities in developmental dyslexia: an ALE meta-analysis. PLoS One. 2012;7(8):e43122. doi: 10.1371/journal.pone.0043122. Epub 2012 Aug 20.

  PMID: 22916214 RESULT

• 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 RESULT

• 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.

  PMID: 20471313 RESULT

• Berger I, Dakwar-Kawar O, Grossman ES, Nahum M, Cohen Kadosh R. Scaffolding the attention-deficit/hyperactivity disorder brain using transcranial direct current and random noise stimulation: A randomized controlled trial. Clin Neurophysiol. 2021 Mar;132(3):699-707. doi: 10.1016/j.clinph.2021.01.005. Epub 2021 Jan 27.

  PMID: 33561725 RESULT

• Breitling C, Zaehle T, Dannhauer M, Tegelbeckers J, Flechtner HH, Krauel K. Comparison between conventional and HD-tDCS of the right inferior frontal gyrus in children and adolescents with ADHD. Clin Neurophysiol. 2020 May;131(5):1146-1154. doi: 10.1016/j.clinph.2019.12.412. Epub 2020 Jan 24.

  PMID: 32029377 RESULT

• Paulesu E, Danelli L, Berlingeri M. Reading the dyslexic brain: multiple dysfunctional routes revealed by a new meta-analysis of PET and fMRI activation studies. Front Hum Neurosci. 2014 Nov 11;8:830. doi: 10.3389/fnhum.2014.00830. eCollection 2014.

  PMID: 25426043 RESULT

• Richlan F, Kronbichler M, Wimmer H. Structural abnormalities in the dyslexic brain: a meta-analysis of voxel-based morphometry studies. Hum Brain Mapp. 2013 Nov;34(11):3055-65. doi: 10.1002/hbm.22127. Epub 2012 Jun 19.

  PMID: 22711189 RESULT

• Vandermosten M, Boets B, Wouters J, Ghesquiere P. A qualitative and quantitative review of diffusion tensor imaging studies in reading and dyslexia. Neurosci Biobehav Rev. 2012 Jul;36(6):1532-52. doi: 10.1016/j.neubiorev.2012.04.002. Epub 2012 Apr 17.

  PMID: 22516793 RESULT

MeSH Terms

Conditions

Dyslexia; Neurodevelopmental Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychology Unit

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)