An interventional study of Active tDCS and Active tRNS in Developmental Dyslexia, sponsored by Bambino Gesù Hospital and Research Institute. Enrolling by invitation at 1 site in Italy. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Bambino Gesù Hospital and Research Institute · Not applicable, Interventional, and Treatment
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.
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:
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.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's planned enrollment of 24 is below the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 54 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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 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 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.
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.
Time frame: during procedure
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: during procedure
Plan to share: No
Started May 2023 (actual). Primary completion is estimated for Mar 2025, 22 months after the start.
Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's planned 22 months is close to that.
Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.
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Bambino Gesù Hospital and Research Institute