Developmental DyslexiaNCT05832060
Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
A study testing Active tDCS and Active tRNS 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 random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal… 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 tDCS and Active tRNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 1 Mar 2025
- 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
- Children and adolescents with dyslexia (DSM-5, APA 2013)
- IQ ≥ 85
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study design is within-subject, randomized stratified, double blind, placebo-controlled.
A group of children and adolescents with DD will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. tRNS over bilateral TPC; 2. anodal tDCS over left TPC (cathode over right TPC); 3. sham tRNS or tDCS. During stimulation (both real and sham), participants will undergo a concomitant reading task.
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS and tDCS, can improve the outcome of individuals with DD.
The protocol will allow the investigators to:
- comparing the efficacy of tDCS and tRNS over TPC in improving reading abilities,
- comparing the safety and tolerability of tDCS and tRNS in children and adolescents.
The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD, based on the two most used brain stimulation techniques in pediatric population.
- Conditions
- Developmental Dyslexia
- Being tested
- Active tDCS, Active tRNS, Sham tRNS or tDCS
- 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
- 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 tDCSDevice
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.
Active tRNSDevice
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 tRNS or tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during procedure
Secondary outcomes (7)
Text reading speed (Experimental reading task)
Change from baseline in text reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS 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).
Measured: during procedure
Experimental reading task: high-frequency word reading accuracy
Change from baseline in high-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency 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.
Measured: during procedure
Experimental reading task: high-frequency word reading speed
Change from baseline in high-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency 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).
Measured: during procedure
Experimental reading task: low-frequency word reading accuracy
Change from baseline in low-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency 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.
Measured: during procedure
Experimental reading task: low-frequency word reading speed
Change from baseline in low-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency 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).
Measured: during procedure
Experimental reading task: non-word reading accuracy
Change from baseline in non-word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS 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.
Measured: during procedure
Experimental reading task: non-word reading speed
Change from baseline in non-word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS 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).
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 posted27 Apr 2023
- Study start1 May 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)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
- 24 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
- NCT05832060
- Sponsor's protocol ID
- 2639_OPBG_2021
- Status last verified
- Sep 2023
- First submitted
- 3 Apr 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12114001Temple 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.
PubMed 12604786Hoeft 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.
PubMed 21173250Hoeft 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.
PubMed 17050709Shaywitz 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.
PubMed 9482939Bakker DJ. Treatment of developmental dyslexia: a review. Pediatr Rehabil. 2006 Jan-Mar;9(1):3-13. doi: 10.1080/13638490500065392.
PubMed 16352500Simos 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.
PubMed 11971088Stuss DT. The future of cognitive neurorehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):755-68. doi: 10.1080/09602011.2011.605590. Epub 2011 Sep 27.
PubMed 21950776Looi 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.
PubMed 28680099Nitsche 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.
PubMed 12803972Fregni 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.
PubMed 15999258Cattaneo 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.
PubMed 21477637Schlaug 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.
PubMed 19064743Baker 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.
PubMed 20395612Monti 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.
PubMed 18096677
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
- ClinicalTrials.gov ID
- NCT05832060
- Acronym / sponsor ID
- 2639_OPBG_2021
- Conditions
- Developmental Dyslexia
- Keywords
- Children, Adolescents, tRNS, transcranial random noise stimulation, tDCS, transcranial direct current stimulation, neurodevelopmental disorders, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Apr 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 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.
Detailed description
The study design is within-subject, randomized stratified, double blind, placebo-controlled.
A group of children and adolescents with DD will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. tRNS over bilateral TPC; 2. anodal tDCS over left TPC (cathode over right TPC); 3. sham tRNS or tDCS. During stimulation (both real and sham), participants will undergo a concomitant reading task.
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS and tDCS, can improve the outcome of individuals with DD.
The protocol will allow the investigators to:
- comparing the efficacy of tDCS and tRNS over TPC in improving reading abilities,
- comparing the safety and tolerability of tDCS and tRNS in children and adolescents.
The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD, based on the two most used brain stimulation techniques in pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tDCS, tRNS, Sham | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Active left anodal/right cathodal tDCS over TPC 2. Active tRNS over bilateral TPC 3. Sham tRNS or tDCS over bilateral TPC |
| tDCS, Sham, tRNS | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Active left anodal/right cathodal tDCS over TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active tRNS over bilateral TPC |
| tRNS, tDCS, Sham | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Active tRNS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Sham tRNS or tDCS over bilateral TPC |
| tRNS, Sham, tDCS | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Active tRNS over bilateral TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC |
| Sham, tDCS, tRNS | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Sham tRNS or tDCS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Active tRNS over bilateral TPC |
| Sham, tRNS, tDCS | Experimental | Device: Active tDCS, Device: Active tRNS, Device: Sham tRNS or tDCS1. Sham tRNS or tDCS over bilateral TPC 2. Active tRNS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and adolescents with dyslexia (DSM-5, APA 2013)
- IQ ≥ 85
Key exclusion criteria (4 listed)
- 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.
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 tDCSActive 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. | Device | Sham, tDCS, tRNS, Sham, tRNS, tDCS, tDCS, Sham, tRNS, tDCS, tRNS, Sham, tRNS, Sham, tDCS, tRNS, tDCS, Sham |
| Active tRNSActive 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. | Device | Sham, tDCS, tRNS, Sham, tRNS, tDCS, tDCS, Sham, tRNS, tDCS, tRNS, Sham, tRNS, Sham, tDCS, tRNS, tDCS, Sham |
| Sham tRNS or tDCSSham 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. | Device | Sham, tDCS, tRNS, Sham, tRNS, tDCS, tDCS, Sham, tRNS, tDCS, tRNS, Sham, tRNS, Sham, tDCS, tRNS, tDCS, Sham |
Primary outcome
Text reading accuracy (Experimental reading task)
Time frame: during procedure
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.
7 secondary outcomes
Text reading speed (Experimental reading task)
Time frame: during procedure
Experimental reading task: high-frequency word reading accuracy
Time frame: during procedure
Experimental reading task: high-frequency word reading speed
Time frame: during procedure
Experimental reading task: low-frequency word reading accuracy
Time frame: during procedure
Experimental reading task: low-frequency word reading speed
Time frame: during procedure
Experimental reading task: non-word reading accuracy
Time frame: during procedure
Experimental reading task: non-word reading speed
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 15 Sep 2023.
- Results publication: PubMed 12114001Shaywitz 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.
- Results publication: PubMed 12604786Temple 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.
- Results publication: PubMed 21173250Hoeft 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.
- Results publication: PubMed 17050709Hoeft 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.
- Results publication: PubMed 9482939Shaywitz 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.
- Results publication: PubMed 16352500Bakker DJ. Treatment of developmental dyslexia: a review. Pediatr Rehabil. 2006 Jan-Mar;9(1):3-13. doi: 10.1080/13638490500065392.
- Results publication: PubMed 11971088Simos 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.
- Results publication: PubMed 21950776Stuss DT. The future of cognitive neurorehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):755-68. doi: 10.1080/09602011.2011.605590. Epub 2011 Sep 27.
- Results publication: PubMed 28680099Looi 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.
- Results publication: PubMed 12803972Nitsche 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.
- Results publication: PubMed 15999258Fregni 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.
- Results publication: PubMed 21477637Cattaneo 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 tDCS and Active tRNS 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 2 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 15 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text reading accuracy (Experimental reading task) (time frame: during procedure). 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 NCT05832060, which also lists 47 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 15 Sep 2023.