NCT05972200

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 direct current stimulation (tDCS) over left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5/MT pathway, cerebral areas usually disrupted in individuals with DD. The investigators hypothesized that active tDCS over V5/MT will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo condition) tDCS over V5/MT or active (control condition) tDCS over V1 will not have significant effect in improving reading skills. Further, both active and sham tDCS will be safe and well tolerated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

July 25, 2023

Last Update Submit

August 2, 2023

Conditions

Developmental Dyslexia

Keywords

ChildrenAdolescentstDCStranscranial direct current stimulationneurodevelopmental disordersnon-invasive brain stimulationtranscranial electrical stimulationEEGreading abilities

Outcome Measures

Primary Outcomes (2)

  • Text reading accuracy (Experimental reading task)

    Change in text reading accuracy from baseline compared after to Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham 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. The time points will be pre- (baseline) vs post-stimulation session.

    during procedure

  • Text reading speed (Experimental reading task)

    Change in text reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Text reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds). The time points will be pre- (baseline) vs post-stimulation session.

    during procedure

Secondary Outcomes (9)

  • Word reading accuracy (Experimental reading task)

    during procedure

  • Word reading speed (Experimental reading task)

    during procedure

  • Non-word reading accuracy (Experimental reading task)

    during procedure

  • Non-word reading speed (Experimental reading task)

    during procedure

  • Right visual hemisphere-motion perception (Experimental reading task)

    during procedure

  • +4 more secondary outcomes

Study Arms (6)

HD-tDCS V5/MT, HD-tDCS V1, Sham

EXPERIMENTAL

1. Active HD-tDCS over V5/MT 2. Active HD-tDCS over V1 3. Sham HD-tDCS over V5/MT or V1

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

HD-tDCS V5/MT, Sham, HD-tDCS V1

EXPERIMENTAL

1. Active HD-tDCS over V5/MT 2. Sham HD-tDCS over V5/MT or V1 3. Active HD-tDCS over V1

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

HD-tDCS V1, HD-tDCS V5/MT, Sham

EXPERIMENTAL

1. Active HD-tDCS over V1 2. Active HD-tDCS over V5/MT 3. Sham HD-tDCS over V5/MT or V1

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

HD-tDCS V1, Sham, HD-tDCS V5/MT

EXPERIMENTAL

1. Active HD-tDCS over V1 2. Sham HD-tDCS over V5/MT or V1 3. Active HD-tDCS over V5/MT

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

Sham, HD-tDCS V5/MT, HD-tDCS V1

EXPERIMENTAL

1. Sham HD-tDCS over V5/MT or V1 2. Active HD-tDCS over V5/MT 3. Active HD-tDCS over V1

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

Sham, HD-tDCS V1, HD-tDCS V5/MT

EXPERIMENTAL

1. Sham HD-tDCS over V5/MT or V1 2. Active HD-tDCS over V1 3. Active HD-tDCS over V5/MT

Device: Active HD-tDCS over V5/MTDevice: Active HD-tDCS over V1Device: Sham HD-tDCS over V5/MT or V1

Interventions

Active HD-tDCS over V5/MTDEVICE

For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V5/MT, whereas the other 4 electrodes return electrical currents that flow away from that area. V5/MT will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.

HD-tDCS V1, HD-tDCS V5/MT, ShamHD-tDCS V1, Sham, HD-tDCS V5/MTHD-tDCS V5/MT, HD-tDCS V1, ShamHD-tDCS V5/MT, Sham, HD-tDCS V1Sham, HD-tDCS V1, HD-tDCS V5/MTSham, HD-tDCS V5/MT, HD-tDCS V1
Active HD-tDCS over V1DEVICE

For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V1, whereas the other 4 electrodes return electrical currents that flow away from that area. V1 will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.

HD-tDCS V1, HD-tDCS V5/MT, ShamHD-tDCS V1, Sham, HD-tDCS V5/MTHD-tDCS V5/MT, HD-tDCS V1, ShamHD-tDCS V5/MT, Sham, HD-tDCS V1Sham, HD-tDCS V1, HD-tDCS V5/MTSham, HD-tDCS V5/MT, HD-tDCS V1
Sham HD-tDCS over V5/MT or V1DEVICE

Sham HD-tDCS will be delivered over left V5/MT or left V1. 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 (0 mA) during the rest of the session without the participants awareness. .

HD-tDCS V1, HD-tDCS V5/MT, ShamHD-tDCS V1, Sham, HD-tDCS V5/MTHD-tDCS V5/MT, HD-tDCS V1, ShamHD-tDCS V5/MT, Sham, HD-tDCS V1Sham, HD-tDCS V1, HD-tDCS V5/MTSham, HD-tDCS V5/MT, HD-tDCS V1

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Italian speakers right-handed children and adolescents with dyslexia (DSM-5, APA 2013);
  • Word/nonword/text reading accuracy and/or speed at least 2 Standard Deviations below the mean for school-age;
  • nv IQ ≥ 85;
  • normal hearing and normal or corrected-to-normal vision.

You may not qualify if:

  • Having a comorbidity with other primary psychiatric/neurological diagnosis (e.g., depression, anxiety, autism, ADHD);
  • Having a personal history of neurological/medical/genetic diseases;
  • Having ongoing drug treatment influencing brain function;
  • Having epilepsy o family history of epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Roma, 00165, Italy

RECRUITING

Related Publications (34)

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.): DSM 5. Washington, DC: American Psychiatric Association. 2013.

    BACKGROUND

  • Snowling, M. Dyslexia, 2nd ed.; Blackwell Publishing: Oxford, UK. 2000.

    BACKGROUND

  • Wolf M, Bowers PG. The double-deficit hypothesis for the developmental dyslexias. Journal of Educational Psychology. 1999; 91(3): 415-438.

    BACKGROUND

  • Menghini D, Finzi A, Benassi M, Bolzani R, Facoetti A, Giovagnoli S, Ruffino M, Vicari S. Different underlying neurocognitive deficits in developmental dyslexia: a comparative study. Neuropsychologia. 2010 Mar;48(4):863-72. doi: 10.1016/j.neuropsychologia.2009.11.003. Epub 2009 Nov 10.

    PMID: 19909762RESULT

  • Vellutino FR, Fletcher JM, Snowling MJ, Scanlon DM. Specific reading disability (dyslexia): what have we learned in the past four decades? J Child Psychol Psychiatry. 2004 Jan;45(1):2-40. doi: 10.1046/j.0021-9630.2003.00305.x.

    PMID: 14959801RESULT

  • Melby-Lervag M, Lyster SA, Hulme C. Phonological skills and their role in learning to read: a meta-analytic review. Psychol Bull. 2012 Mar;138(2):322-52. doi: 10.1037/a0026744. Epub 2012 Jan 16.

    PMID: 22250824RESULT

  • Schulte-Korne G, Bruder J. Clinical neurophysiology of visual and auditory processing in dyslexia: a review. Clin Neurophysiol. 2010 Nov;121(11):1794-809. doi: 10.1016/j.clinph.2010.04.028. Epub 2010 May 31.

    PMID: 20570212RESULT

  • Vidyasagar TR, Pammer K. Dyslexia: a deficit in visuo-spatial attention, not in phonological processing. Trends Cogn Sci. 2010 Feb;14(2):57-63. doi: 10.1016/j.tics.2009.12.003. Epub 2010 Jan 14.

    PMID: 20080053RESULT

  • Franceschini S, Gori S, Ruffino M, Pedrolli K, Facoetti A. A causal link between visual spatial attention and reading acquisition. Curr Biol. 2012 May 8;22(9):814-9. doi: 10.1016/j.cub.2012.03.013. Epub 2012 Apr 5.

    PMID: 22483940RESULT

  • Bosse ML, Tainturier MJ, Valdois S. Developmental dyslexia: the visual attention span deficit hypothesis. Cognition. 2007 Aug;104(2):198-230. doi: 10.1016/j.cognition.2006.05.009. Epub 2006 Jul 21.

    PMID: 16859667RESULT

  • Stenneken P, Egetemeir J, Schulte-Korne G, Muller HJ, Schneider WX, Finke K. Slow perceptual processing at the core of developmental dyslexia: a parameter-based assessment of visual attention. Neuropsychologia. 2011 Oct;49(12):3454-65. doi: 10.1016/j.neuropsychologia.2011.08.021. Epub 2011 Aug 31.

    PMID: 21903119RESULT

  • Giovagnoli G, Vicari S, Tomassetti S, Menghini D. The Role of Visual-Spatial Abilities in Dyslexia: Age Differences in Children's Reading? Front Psychol. 2016 Dec 21;7:1997. doi: 10.3389/fpsyg.2016.01997. eCollection 2016.

    PMID: 28066311RESULT

  • Wang Z, Cheng-Lai A, Song Y, Cutting L, Jiang Y, Lin O, Meng X, Zhou X. A perceptual learning deficit in Chinese developmental dyslexia as revealed by visual texture discrimination training. Dyslexia. 2014 Aug;20(3):280-96. doi: 10.1002/dys.1475. Epub 2014 Mar 18.

    PMID: 24643918RESULT

  • Bowers PG, Wolf, M. Theoretical links among naming speed, precise timing mechanisms and orthographic skill in dyslexia. Reading and Writing.1993; 51: 69-85.

    RESULT

  • Richlan F, Kronbichler M, Wimmer H. Meta-analyzing brain dysfunctions in dyslexic children and adults. Neuroimage. 2011 Jun 1;56(3):1735-42. doi: 10.1016/j.neuroimage.2011.02.040. Epub 2011 Feb 19.

    PMID: 21338695RESULT

  • Richlan F. Developmental dyslexia: dysfunction of a left hemisphere reading network. Front Hum Neurosci. 2012 May 1;6:120. doi: 10.3389/fnhum.2012.00120. eCollection 2012.

    PMID: 22557962RESULT

  • Livingstone MS, Rosen GD, Drislane FW, Galaburda AM. Physiological and anatomical evidence for a magnocellular defect in developmental dyslexia. Proc Natl Acad Sci U S A. 1991 Sep 15;88(18):7943-7. doi: 10.1073/pnas.88.18.7943.

    PMID: 1896444RESULT

  • Galaburda AM, Menard MT, Rosen GD. Evidence for aberrant auditory anatomy in developmental dyslexia. Proc Natl Acad Sci U S A. 1994 Aug 16;91(17):8010-3. doi: 10.1073/pnas.91.17.8010.

    PMID: 8058748RESULT

  • Giraldo-Chica M, Hegarty JP 2nd, Schneider KA. Morphological differences in the lateral geniculate nucleus associated with dyslexia. Neuroimage Clin. 2015 Mar 20;7:830-6. doi: 10.1016/j.nicl.2015.03.011. eCollection 2015.

    PMID: 26082892RESULT

  • Muller-Axt C, Anwander A, von Kriegstein K. Altered Structural Connectivity of the Left Visual Thalamus in Developmental Dyslexia. Curr Biol. 2017 Dec 4;27(23):3692-3698.e4. doi: 10.1016/j.cub.2017.10.034. Epub 2017 Nov 16.

    PMID: 29153326RESULT

  • Tschentscher N, Ruisinger A, Blank H, Diaz B, von Kriegstein K. Reduced Structural Connectivity Between Left Auditory Thalamus and the Motion-Sensitive Planum Temporale in Developmental Dyslexia. J Neurosci. 2019 Feb 27;39(9):1720-1732. doi: 10.1523/JNEUROSCI.1435-18.2018. Epub 2019 Jan 14.

    PMID: 30643025RESULT

  • Kirimoto H, Ogata K, Onishi H, Oyama M, Goto Y, Tobimatsu S. Transcranial direct current stimulation over the motor association cortex induces plastic changes in ipsilateral primary motor and somatosensory cortices. Clin Neurophysiol. 2011 Apr;122(4):777-83. doi: 10.1016/j.clinph.2010.09.025. Epub 2010 Nov 11.

    PMID: 21074492RESULT

  • 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: 22305346RESULT

  • Younger JW, Randazzo Wagner M, Booth JR. Weighing the Cost and Benefit of Transcranial Direct Current Stimulation on Different Reading Subskills. Front Neurosci. 2016 Jun 7;10:262. doi: 10.3389/fnins.2016.00262. eCollection 2016.

    PMID: 27375421RESULT

  • Younger JW, Booth JR. Parietotemporal Stimulation Affects Acquisition of Novel Grapheme-Phoneme Mappings in Adult Readers. Front Hum Neurosci. 2018 Mar 23;12:109. doi: 10.3389/fnhum.2018.00109. eCollection 2018.

    PMID: 29628882RESULT

  • 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: 25701796RESULT

  • 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: 26848997RESULT

  • 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: 26890096RESULT

  • 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: 29550525RESULT

  • Rios DM, Correia Rios M, Bandeira ID, Queiros Campbell F, de Carvalho Vaz D, Lucena R. Impact of Transcranial Direct Current Stimulation on Reading Skills of Children and Adolescents With Dyslexia. Child Neurol Open. 2018 Oct 4;5:2329048X18798255. doi: 10.1177/2329048X18798255. eCollection 2018.

    PMID: 30306098RESULT

  • Lazzaro G, Costanzo F, Varuzza C, Rossi S, De Matteis ME, Vicari S, Menghini D. Individual differences modulate the effects of tDCS on reading in children and adolescents with dyslexia. Scientific Studies of Reading. 2021; 25(6): 1-17.

    RESULT

  • Lazzaro G, Costanzo F, Varuzza C, Rossi S, Vicari S, Menghini D. Effects of a short, intensive, multi-session tDCS treatment in developmental dyslexia: Preliminary results of a sham-controlled randomized clinical trial. Prog Brain Res. 2021;264:191-210. doi: 10.1016/bs.pbr.2021.01.015.

    PMID: 34167656RESULT

  • Battisti A, Lazzaro G, Costanzo F, Varuzza C, Rossi S, Vicari S, Menghini D. Effects of a short and intensive transcranial direct current stimulation treatment in children and adolescents with developmental dyslexia: A crossover clinical trial. Front Psychol. 2022 Sep 9;13:986242. doi: 10.3389/fpsyg.2022.986242. eCollection 2022.

    PMID: 36160506RESULT

  • Somma F, Lazzaro G, Rima S, Rainich K, Muller-Axt C, Schmid MC, Vicari S, von Kriegstein K, Menghini D. Detecting the contribution of V5/MT in reading, reading-related tasks, eye-movements and EEG-oscillations in children and adolescents with developmental dyslexia via high-definition tDCS: a protocol study. BMC Psychol. 2025 Jul 7;13(1):744. doi: 10.1186/s40359-025-03036-w.

    PMID: 40624571DERIVED

MeSH Terms

Conditions

DyslexiaNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Deny Menghini

CONTACT

06.6859.2875deny.menghini@opbg.net

Giulia Lazzaro

CONTACT

giulia.lazzaro@opbg.net

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

July 25, 2023

First Posted

August 2, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)