Developmental DyslexiaNCT05972200
V5/MT Stimulation on Reading and Reading-related Measures in Developmental Dyslexia
A study testing Active HD-tDCS over V5/MT and Active HD-tDCS over V1 in people with Developmental Dyslexia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Active HD-tDCS over V5/MT and Active HD-tDCS over V1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Giulia Lazzaro contact
Italy1 site, 1 recruiting
- Recruiting
Bambino Gesù Hospital and Research Institute
Roma, 00165
Deny Menghini, 06.6859.2875, deny.menghini@opbg.net
Rita Alparone, 06.6859.2859, rita.alparone@opbg.net
About this study
Official title: Probing the Efficacy of V5/MT Stimulation on Reading and Reading-related Measures in Children and Adolescents With Developmental Dyslexia
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.
Read the detailed description
Over the last few decades, a huge number of studies has revealed that Developmental Dyslexia (DD), a brain-based neurodevelopmental disorder characterized by a severe and persistent impairment in the acquisition of reading skills may depend on multiple neurocognitive impairments, ranging from language-specific to cognitive-general deficits. Besides the most influential hypothesis of a phonological core deficit, there is also evidence for difficulties in low-level visual-temporal information processing, as the magnocellular deficit theory supports, as well as for visual-spatial attentional deficits, visual-perceptual impairments, and rapid automatized naming (RAN)-speed deficits.
Replicated structural/functional neuroimaging studies have demonstrated a DD hypoactivation relative to typical readers in the left temporo-occipital regions-critical for the automatic visual processing of word strings or print-and in the left temporo-parietal regions-important for grapheme-to-phoneme mapping.
Moreover, findings from animal models and post mortem studies in humans suggest that DD might also be associated with structural alterations in subcortical sensory pathways, particularly in visual and auditory thalamic nuclei and in their connections with high-order sensory cortices (i.e., the left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5/MT pathway and the left hemispheric direct Medial Geniculate Body (MGB)-mPT pathway). In addition, in adults with DD, left V5/MT-LGN connectivity strength correlated with RAN abilities - a key deficit in DD.
A number of studies have demonstrated the positive effect of transcranial direct current stimulation (tDCS), a non-invasive brain stimulation used for transiently modifying neural activity of target areas, on reading and, particularly, in DD.
However, the few non-invasive brain stimulation studies on improving reading in DD yielded heterogeneous results and this variability might be partly due to the lack of neurobiological understanding of the underlying DD mechanism or to the use of traditional tDCS rather than a more focal technique such as the high-definition tDCS (HD-tDCS).
Starting from this, the aim of the current study is testing the effectiveness of a cutting-edge stimulation technique (i.e., HD-tDCS) in a within-subject experiment involving children and adolescents with DD. Especially, we will work to test i) the specific effect of HD-tDCS over high-order sensory cortices (i.e., V5/MT vs V1) on reading in children with DD; ii) the preconditions and neurobiological mechanisms that lead to high treatment outcomes.
If the stimulation over V5/MT is effective and specifically related to reading improvement, our results could help to i) understand the contribution and neurobiological mechanism of V5/MT in reading of children and adolescents with DD; ii) select criteria for potential responders to non-invasive brain stimulation; iii) develop evidence-based interventions in DD.
- Conditions
- Developmental Dyslexia
- Being tested
- Active HD-tDCS over V5/MT, Active HD-tDCS over V1, Sham HD-tDCS over V5/MT or V1
- Keywords
- Children, Adolescents, tDCS, transcranial direct current stimulation, neurodevelopmental disorders, non-invasive brain stimulation, transcranial electrical stimulation, EEG, reading abilities
- Medical subject headings
- Dyslexia, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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. .
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: 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 Receives: Device: Active HD-tDCS over V5/MT; Device: Active HD-tDCS over V1; Device: Sham HD-tDCS over V5/MT or V1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: during procedure
Secondary outcomes (9)
Word reading accuracy (Experimental reading task)
Change in word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Word 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.
Measured: during procedure
Word reading speed (Experimental reading task)
Change in word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than during Active HD-tDCS over V1 and Sham sessions. Word 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.
Measured: during procedure
Non-word reading accuracy (Experimental reading task)
Change in non-word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word 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.
Measured: during procedure
Non-word reading speed (Experimental reading task)
Change in non-word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word 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.
Measured: during procedure
Right visual hemisphere-motion perception (Experimental reading task)
Change in right visual hemisphere-motion perception from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Right visual hemisphere-motion perception is considered as the number of correct saccades.
The time points will be pre- (baseline) vs post-stimulation session.
Measured: during procedure
Rapid automatized naming letter and number (Experimental reading task)
Change in rapid automatized naming letter and number from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Rapid automatized naming letter and number is considered as the total time spent (in seconds) to complete the task.
The time points will be pre- (baseline) vs post-stimulation session.
Measured: during procedure
Phoneme blending (Experimental reading task)
Change in phoneme blending from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Phoneme blending is considered as the number of correctly blended phonemes.
The time points will be pre- (baseline) vs post-stimulation session.
Measured: during procedure
Eye-movements during reading (Experimental reading task)
Change in eye-movements from baseline compared to after reading during Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Eye-movements during reading is considered as the number of saccades and the number of dwells.
The time points will be pre- (baseline) vs post-stimulation session.
Measured: during procedure
Spontaneous EEG (Experimental reading task)
Change in spontaneous EEG from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Spontaneous EEG is considered as the individual alpha-peak frequency and the beta and theta/gamma oscillations.
The time points will be pre- (baseline) vs post-stimulation session.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deny Menghini, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972200
- Sponsor's protocol ID
- 3073_OPBG_2023
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.): DSM 5. Washington, DC: American Psychiatric Association. 2013.
Snowling, M. Dyslexia, 2nd ed.; Blackwell Publishing: Oxford, UK. 2000.
Wolf M, Bowers PG. The double-deficit hypothesis for the developmental dyslexias. Journal of Educational Psychology. 1999; 91(3): 415-438.
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.
PubMed 19909762Vellutino 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.
PubMed 14959801Melby-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.
PubMed 22250824Schulte-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.
PubMed 20570212Vidyasagar 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.
PubMed 20080053Franceschini 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.
PubMed 22483940Bosse 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.
PubMed 16859667Stenneken 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.
PubMed 21903119Giovagnoli 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.
PubMed 28066311Wang 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.
PubMed 24643918Bowers PG, Wolf, M. Theoretical links among naming speed, precise timing mechanisms and orthographic skill in dyslexia. Reading and Writing.1993; 51: 69-85.
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.
PubMed 21338695
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Efficacy of V5/MT Stimulation on Reading and Reading-related Measures in Children and Adolescents With Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT05972200
- Acronym / sponsor ID
- 3073_OPBG_2023
- Conditions
- Developmental Dyslexia
- Keywords
- Children, Adolescents, tDCS, transcranial direct current stimulation, neurodevelopmental disorders, non-invasive brain stimulation, transcranial electrical stimulation, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over the last few decades, a huge number of studies has revealed that Developmental Dyslexia (DD), a brain-based neurodevelopmental disorder characterized by a severe and persistent impairment in the acquisition of reading skills may depend on multiple neurocognitive impairments, ranging from language-specific to cognitive-general deficits. Besides the most influential hypothesis of a phonological core deficit, there is also evidence for difficulties in low-level visual-temporal information processing, as the magnocellular deficit theory supports, as well as for visual-spatial attentional deficits, visual-perceptual impairments, and rapid automatized naming (RAN)-speed deficits.
Replicated structural/functional neuroimaging studies have demonstrated a DD hypoactivation relative to typical readers in the left temporo-occipital regions-critical for the automatic visual processing of word strings or print-and in the left temporo-parietal regions-important for grapheme-to-phoneme mapping.
Moreover, findings from animal models and post mortem studies in humans suggest that DD might also be associated with structural alterations in subcortical sensory pathways, particularly in visual and auditory thalamic nuclei and in their connections with high-order sensory cortices (i.e., the left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5/MT pathway and the left hemispheric direct Medial Geniculate Body (MGB)-mPT pathway). In addition, in adults with DD, left V5/MT-LGN connectivity strength correlated with RAN abilities - a key deficit in DD.
A number of studies have demonstrated the positive effect of transcranial direct current stimulation (tDCS), a non-invasive brain stimulation used for transiently modifying neural activity of target areas, on reading and, particularly, in DD.
However, the few non-invasive brain stimulation studies on improving reading in DD yielded heterogeneous results and this variability might be partly due to the lack of neurobiological understanding of the underlying DD mechanism or to the use of traditional tDCS rather than a more focal technique such as the high-definition tDCS (HD-tDCS).
Starting from this, the aim of the current study is testing the effectiveness of a cutting-edge stimulation technique (i.e., HD-tDCS) in a within-subject experiment involving children and adolescents with DD. Especially, we will work to test i) the specific effect of HD-tDCS over high-order sensory cortices (i.e., V5/MT vs V1) on reading in children with DD; ii) the preconditions and neurobiological mechanisms that lead to high treatment outcomes.
If the stimulation over V5/MT is effective and specifically related to reading improvement, our results could help to i) understand the contribution and neurobiological mechanism of V5/MT in reading of children and adolescents with DD; ii) select criteria for potential responders to non-invasive brain stimulation; iii) develop evidence-based interventions in DD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS V5/MT, HD-tDCS V1, Sham | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Active HD-tDCS over V5/MT 2. Active HD-tDCS over V1 3. Sham HD-tDCS over V5/MT or V1 |
| HD-tDCS V5/MT, Sham, HD-tDCS V1 | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Active HD-tDCS over V5/MT 2. Sham HD-tDCS over V5/MT or V1 3. Active HD-tDCS over V1 |
| HD-tDCS V1, HD-tDCS V5/MT, Sham | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Active HD-tDCS over V1 2. Active HD-tDCS over V5/MT 3. Sham HD-tDCS over V5/MT or V1 |
| HD-tDCS V1, Sham, HD-tDCS V5/MT | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Active HD-tDCS over V1 2. Sham HD-tDCS over V5/MT or V1 3. Active HD-tDCS over V5/MT |
| Sham, HD-tDCS V5/MT, HD-tDCS V1 | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Sham HD-tDCS over V5/MT or V1 2. Active HD-tDCS over V5/MT 3. Active HD-tDCS over V1 |
| Sham, HD-tDCS V1, HD-tDCS V5/MT | Experimental | Device: Active HD-tDCS over V5/MT, Device: Active HD-tDCS over V1, Device: Sham HD-tDCS over V5/MT or V11. Sham HD-tDCS over V5/MT or V1 2. Active HD-tDCS over V1 3. Active HD-tDCS over V5/MT |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active HD-tDCS over V5/MTFor 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. | Device | HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V5/MT, HD-tDCS V5/MT, HD-tDCS V1, Sham, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V5/MT, HD-tDCS V1 |
| Active HD-tDCS over V1For 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. | Device | HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V5/MT, HD-tDCS V5/MT, HD-tDCS V1, Sham, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V5/MT, HD-tDCS V1 |
| Sham HD-tDCS over V5/MT or V1Sham 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. . | Device | HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V5/MT, HD-tDCS V5/MT, HD-tDCS V1, Sham, HD-tDCS V5/MT, Sham, HD-tDCS V1, Sham, HD-tDCS V1, HD-tDCS V5/MT, Sham, HD-tDCS V5/MT, HD-tDCS V1 |
Primary outcome
Text reading accuracy (Experimental reading task)
Time frame: during procedure
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.
Text reading speed (Experimental reading task)
Time frame: during procedure
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.
9 secondary outcomes
Word reading accuracy (Experimental reading task)
Time frame: during procedure
Word reading speed (Experimental reading task)
Time frame: during procedure
Non-word reading accuracy (Experimental reading task)
Time frame: during procedure
Non-word reading speed (Experimental reading task)
Time frame: during procedure
Right visual hemisphere-motion perception (Experimental reading task)
Time frame: during procedure
Rapid automatized naming letter and number (Experimental reading task)
Time frame: during procedure
Phoneme blending (Experimental reading task)
Time frame: during procedure
Eye-movements during reading (Experimental reading task)
Time frame: during procedure
Spontaneous EEG (Experimental reading task)
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.): DSM 5. Washington, DC: American Psychiatric Association. 2013.
- BackgroundSnowling, M. Dyslexia, 2nd ed.; Blackwell Publishing: Oxford, UK. 2000.
- BackgroundWolf M, Bowers PG. The double-deficit hypothesis for the developmental dyslexias. Journal of Educational Psychology. 1999; 91(3): 415-438.
- Results publication: PubMed 19909762Menghini 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.
- Results publication: PubMed 14959801Vellutino 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.
- Results publication: PubMed 22250824Melby-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.
- Results publication: PubMed 20570212Schulte-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.
- Results publication: PubMed 20080053Vidyasagar 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.
- Results publication: PubMed 22483940Franceschini 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.
- Results publication: PubMed 16859667Bosse 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.
- Results publication: PubMed 21903119Stenneken 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.
- Results publication: PubMed 28066311Giovagnoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Lazzaro contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active HD-tDCS over V5/MT and Active HD-tDCS over V1 in people with Developmental Dyslexia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deny Menghini (06.6859.2875, deny.menghini@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text reading accuracy (Experimental reading task) (time frame: during procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972200, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.