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IRCT20201211049676N2 IRCT 2023-02-28 Iran University of Medical Sciences the combined intervention of phonological awareness and transcranial direct current stimulation on Rapid Automatized Naming and Verbal Short Term Memory Impact of Phonological Awareness Intervention Combined with Transcranial Direct Current Stimulation on Rapid Automatized Naming and Verbal Short-Term Memory in developmental dyslexia: A Randomized Controlled Trial 2023-03-04 anticipated 28 Complete https://irct.ir/trial/68766 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A computer-based randomization approach was used (www.sealedenvelope.com) to randomly assigned participants to the study groups (active/sham). We included 28 participants and 4 blocks of the same size to create a random archive. A unique code generated by the software was given to participants to conceal the randomization process. These unique codes were used on the cubes representing the type of empirical groups; thus, participants will randomly assign to one of these groups, Blinding description: None of the participants, nor the main therapist (researcher) (performing the phonological awareness training in both groups), and the evaluator (evaluating outcome measures at the 5 evaluation time points) will inform of about group allocations. A sealed opaque envelope approach will be used to conceal groupings. The assistant therapist will received the randomly created intervention assignments within the sealed opaque envelopes. After a participant entered the study, the envelope will be unsealed. Just the assistant therapist who set up the tDCS device will be informed of the about intervention allocation (active or sham). Moreover, the investigator who measured outcomes and conducted the analysis will be also blinded to group allocations. N/A developmental dyslexia. Intervention group: active and sham stimulation. Regardless of group allocation, each participant will go through 15 60-minutes intervention sessions [three times per week (T) for 5 weeks]. Study outcomes will be obtained five times: immediately before treatment (pre-test) (T0), at the end of the fifth intervention session (T1), at the end of the tenth intervention session (T2), immediately after the intervention (T3), and 6 weeks after the end of intervention (T4) by a blinded investigator who will not involved in other parts of the study. The 6-week follow-up will be planned for each participant to evaluate stability of treatment effects in both groups. "phonological awareness Intervention": phonological awareness treatment will be performed in both, the active and sham groups during each session. Each treatment session will be 60 minutes long (15 hours in total). We will derive the phonological awareness intervention program from the ‘‘Gillon Phonological Awareness Training Program’. The Gillon PA treatment program covers nine skills: • Rhyme abilities• Phoneme analysis • Phoneme recognition• Phoneme segmentation • Phoneme blending• Tracing speech sounds • Sound–symbol association • Tracing speech sound with letters • Reading and writing skills. "transcranial direct current stimulation intervention (tDCS)": Participants will be randomly assigned to the sham and anodal tDCS groups. In order to determine the location of electrodes accurately, we will use an EEG cap. The anode and cathode electrodes will be positioned over the left and the right parieto-temporal regions, respectively. An Activa Dose II Iontophoresis Delivery Unit tDCS will be used for stimulation. In the active group, stimulation will be performed by two conductive rubber electrodes. Each electrode will be covered by a sponge pad. The 5 cm x 7 cm electrodes will be positioned on the scalp using an elastic rubber strip. Both sides of the sponge pads will be moistened in dextrose 3.33% and sodium chloride 0.3% solution for better conductivity. Before placing the electrodes on the scalp, the therapist will check the skin of the head for lesions. Electrodes positions will be identical in both, the anodal and sham tDCS groups. The electrode location over the left and the right hemispheres will be determined as half distance between the T3 and P3, and T4 and P4 electrode positions according to the 10-20 international system. The anodal electrode will be positioned over the left parieto-temporal cortex, while the cathode will be placed over the right parieto-temporal cortex. In the active tDCS group, at the beginning of stimulation, the current will be gradually increased over the first 30 seconds up to 1 mA, and will be declined gradually to 0 mA over the last 30 seconds of tDCS. A constant direct current of 1 mA will be applied for 20 minutes. In the sham group, the direct current will be applied for 30 seconds and will be turned off afterwards. This placebo intervention induces tDCS-generated sensations (e.g., irritation and itching) indiscernible by the participants from an active intervention. The combined intervention will be applied three times a week for 5 weeks (15 sessions). tDCS will be applied for 15 sessions simultaneously with phonological awareness (During the 60 minutes of the combined intervention, only 20 minutes tDCS (real or sham) will be provided to the participants).. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data is confidential
public dr reyhane mohamadi
mirdamad avenue
تهران Iran (Islamic Republic of) 1545913487 22227124 mohamadi.r@iums.ac.ir Iran University of Medical Sciences scientific dr seyyedeh samaneh mirahadi
29 bahman avenue
Tabriz Iran (Islamic Republic of) 5164736931 +98 41 3337 2072 saamaneh.milo@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Persian native language reading performance of words and/or non words reading subtests at least 1.5 standard deviations below the population mean according to the NEMA reading and dyslexia test a non-verbal IQ score>85 according to the Wechsler test not having associated disorders or symptoms, including seizures, attention deficit and hyperactivity disorders evaluated by clinical observation and by using Conners’ Rating Scales absence of a non-compensated hearing loss and being right-handed as evaluated by the Edinburgh inventory 7 years 12 years Both a history of a reading-related intervention the use of medication associated with central nervous system disorders Treatment - Devices Intervention group: active and sham stimulation. Regardless of group allocation, each participant will go through 15 60-minutes intervention sessions [three times per week (T) for 5 weeks]. Study outcomes will be obtained five times: immediately before treatment (pre-test) (T0), at the end of the fifth intervention session (T1), at the end of the tenth intervention session (T2), immediately after the intervention (T3), and 6 weeks after the end of intervention (T4) by a blinded investigator who will not involved in other parts of the study. The 6-week follow-up will be planned for each participant to evaluate stability of treatment effects in both groups. "phonological awareness Intervention": phonological awareness treatment will be performed in both, the active and sham groups during each session. Each treatment session will be 60 minutes long (15 hours in total). We will derive the phonological awareness intervention program from the ‘‘Gillon Phonological Awareness Training Program’. The Gillon PA treatment program covers nine skills: • Rhyme abilities• Phoneme analysis • Phoneme recognition• Phoneme segmentation • Phoneme blending• Tracing speech sounds • Sound–symbol association • Tracing speech sound with letters • Reading and writing skills. "transcranial direct current stimulation intervention (tDCS)": Participants will be randomly assigned to the sham and anodal tDCS groups. In order to determine the location of electrodes accurately, we will use an EEG cap. The anode and cathode electrodes will be positioned over the left and the right parieto-temporal regions, respectively. An Activa Dose II Iontophoresis Delivery Unit tDCS will be used for stimulation. In the active group, stimulation will be performed by two conductive rubber electrodes. Each electrode will be covered by a sponge pad. The 5 cm x 7 cm electrodes will be positioned on the scalp using an elastic rubber strip. Both sides of the sponge pads will be moistened in dextrose 3.33% and sodium chloride 0.3% solution for better conductivity. Before placing the electrodes on the scalp, the therapist will check the skin of the head for lesions. Electrodes positions will be identical in both, the anodal and sham tDCS groups. The electrode location over the left and the right hemispheres will be determined as half distance between the T3 and P3, and T4 and P4 electrode positions according to the 10-20 international system. The anodal electrode will be positioned over the left parieto-temporal cortex, while the cathode will be placed over the right parieto-temporal cortex. In the active tDCS group, at the beginning of stimulation, the current will be gradually increased over the first 30 seconds up to 1 mA, and will be declined gradually to 0 mA over the last 30 seconds of tDCS. A constant direct current of 1 mA will be applied for 20 minutes. In the sham group, the direct current will be applied for 30 seconds and will be turned off afterwards. This placebo intervention induces tDCS-generated sensations (e.g., irritation and itching) indiscernible by the participants from an active intervention. The combined intervention will be applied three times a week for 5 weeks (15 sessions). tDCS will be applied for 15 sessions simultaneously with phonological awareness (During the 60 minutes of the combined intervention, only 20 minutes tDCS (real or sham) will be provided to the participants). Rapid automatized naming and verbal short term memory. Timepoint: baseline, end of the fifth and tenth intervention session, end of the intervention and 6 weeks after intervention. Method of measurement: naming and memory tests. Iran University of Medical Sciences Approved 2023-01-24 Ethics committee of Iran University of Medical Sciences Mirdamad avenue Tehran Tehran Iran (Islamic Republic of)