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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972200
Other study ID # 3073_OPBG_2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 31, 2026

Study information

Verified date August 2023
Source Bambino Gesù Hospital and Research Institute
Contact Deny Menghini
Phone 06.6859.2875
Email deny.menghini@opbg.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Italy Bambino Gesù Hospital and Research Institute Roma

Sponsors (1)

Lead Sponsor Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

References & Publications (33)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
Secondary 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.
during procedure
See also
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Completed NCT04382482 - Remotely Controlled Intervention for Developmental Reading and Spelling Disorders Through the Tachidino Platform
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Active, not recruiting NCT03448237 - Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia. N/A
Completed NCT04250701 - Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
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Recruiting NCT03119402 - Effects of the Combination of RRT With tDCS on Dyslexic Adults N/A
Enrolling by invitation NCT04995471 - Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT) N/A