V5/MT Stimulation on Reading and Reading-related Measures in Developmental Dyslexia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorBambino Gesù Hospital and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Active HD-tDCS over V5/MT

    Device

    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 V1

    Device

    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 V1

    Device

    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. .

Treatment groups

36 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: HD-tDCS V5/MT, HD-tDCS V1, ShamExperimental treatment 3 interventions
Group B: HD-tDCS V5/MT, Sham, HD-tDCS V1Experimental treatment 3 interventions
Group C: HD-tDCS V1, HD-tDCS V5/MT, ShamExperimental treatment 3 interventions
Group D: HD-tDCS V1, Sham, HD-tDCS V5/MTExperimental treatment 3 interventions
Group E: Sham, HD-tDCS V5/MT, HD-tDCS V1Experimental treatment 3 interventions
Group F: Sham, HD-tDCS V1, HD-tDCS V5/MTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
during procedure
2

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.

Time frame
during procedure

Secondary outcomes

1

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.

Time frame
during procedure
2

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.

Time frame
during procedure
3

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.

Time frame
during procedure
4

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.

Time frame
during procedure

Other outcomes

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