Protocol summary

Study aim
Evaluating the effectiveness of tDCS on word, non-word reading, irregular words skills, and reading errors in Persian text in children with dyslexia.
Design
A concealed, randomized, blinded, sham-active clinical trial with a parallel-group design of 28 patients, will enroll between April 2020 and Agust 2021 and follow for one month.
Settings and conduct
Intervention in this study in a clinic of education in Baharestan (Tehran province) by a therapist for 12 sessions. Both participants and the therapist are blind to whether the participant is in the sham or intervention group.
Participants/Inclusion and exclusion criteria
Have normal IQ (between 85 and 110). Being right-handed. Absence of other psychiatric disorders Utilizing Persian as the mother tongue (Persian native speakers) Absence of sensory-motor disorders Absence of epilepsy Filling out the informed consent form by the parent
Intervention groups
For active stimulation the direct current will also be transferred using a saline-soaked pair of surface sponge electrodes (thickness = 0.3 cm; square meters = 25 cm2), which are fixed by a headband. Stimulation will be deliver over the tempo-parietal region (Anodal electrode over the midway between P7 and TP7; cathodal electrode over the midway between P8 and TP8). We apply current at a density of 0.057 mA/cm2. For sham stimulation, the same montage will use. However, the current was ramped up for 30 second and then ramped down.
Main outcome variables
Non-word reading, irregular word reading, reading errors (misreading, substitution, elimination, addition)

General information

Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number: IRCT20180522039775N2
Registration date: 2024-03-25, 1403/01/06
Registration timing: prospective

Last update: 2024-03-25, 1403/01/06
Update count: 0
Registration date
2024-03-25, 1403/01/06
Registrant information
Name
Mehdi Rezaei
Name of organization / entity
Lorestan university
Country
Iran (Islamic Republic of)
Phone
+98 21 5675 9071
Email address
rezaee.mehdi15@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-09, 1403/01/21
Expected recruitment end date
2024-08-11, 1403/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Transcranial Direct Current Stimulation (tDCS) on the reading skills of children with dyslexia
Public title
Investigating effect of brain stimulation on dyslexia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have normal IQ (between 85 and 110). Being right-handed. Presence of dyslexia diagnostic criteria based on DSM-V criteria Utilizing Persian as the mother tongue (Persian native speakers) Filling out the informed consent form by the parent Age range from 9 to 12 years
Exclusion criteria:
Concurrent neurological illness Comorbidity with other psychiatric disorders Active physical disorders Wearing a cardiac pacemaker and metal parts in the head Presence of sensory-motor disorders Presence of epilepsy Receiving other treatments at the same time
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the active and sham groups. A computer-based randomization approach will be used (www.sealedenvelope.com). We will include 40 participants and five blocks of the same size to create a random archive. For concealment in the randomization process, a unique code will be provided to each participant that generate by the software. These codes randomly associate with the cubes that represente the intervention groups. Since the study was double-blind, none of the participants or therapists were informed which group (active or sham) each participant was assigned to.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study undermentioned persons will be blind: Evaluator relative to pre and post-intervention assessments - Therapist relative to Sham-active intervention execution (Sham: The placebo state in which the device electrodes are placed on the scalp to create a placebo effect, but no current is sent to the brain. Active: Active stimulation mode (positively charged) where the electrodes are on the scalp and a current of 1 mili Amper (mA) is directed to the brain for 20 minutes, Participants relative to receiving Sham-active intervention execution
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Birjand
Street address
Daneshgah Blvd, University of Birjand
City
Birjand
Province
South Khorasan
Postal code
9717434765
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.BIRJAND.REC.1402.015

Health conditions studied

1

Description of health condition studied
Dyslexia
ICD-10 code
R48
ICD-10 code description
Dyslexia and other symbolic dysfunctions, not elsewhere classified

Primary outcomes

1

Description
Word reading (High frequency, low frequency)
Timepoint
Baseline, end of the final treatment session, one month later (follow up)
Method of measurement
Reading and Dyslexia Test (NEMA)

2

Description
Reading errors
Timepoint
Baseline, end of the final treatment session, one month later (follow up)
Method of measurement
Assessment of Persian Reading Ability–Level 1 (APRA)

3

Description
Non-word reading
Timepoint
Baseline, end of the final treatment session, one month later (follow up)
Method of measurement
Non-word reading test

4

Description
Irregular word reading
Timepoint
Baseline, end of the final treatment session, one month later (follow up)
Method of measurement
Irregular word reading test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Direct current (1 mA, 20 min, for six days a week, two weeks) will transferr by a saline-soaked (0.9% NaCl) pair of surface sponge electrodes (size 5 cm x 5cm = 25cm 2 each). Stimulation will be deliver over the temporo-parietal region (anodal electrode over the midway between P7 and TP7; cathodal electrode over the midway between P8 and TP8). Direct current will deliver by a battery-driven stimulator (DC-Stimulator-Plus, NeuroConn GmbH, Ilmenau, Germany) approved for usage in humans. Brain areas will localize using the EEG 10/20 system.The current intensity of 1.5 mA (current density: 0.57 A/m2) for a duration of 20 min will use for 12 sessions.
Category
Treatment - Devices

2

Description
Control group: For sham stimulation, the electrodes will place in the same location and the same montage (1.5 mA, 20 min, for six days a week, two weeks, current density: 0.57 A/m2) will use. However, the current ramp up for 30 second and then ramp down
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Elementary schools
Full name of responsible person
Mehdi Rezaei
Street address
Velayat Ave., Nyaiesh Ave., No 115
City
Nasimshahr
Province
Tehran
Postal code
3766152624
Phone
+98 21 5675 9071
Email
Mehdi.rezaei15@birjand.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Birjand
Full name of responsible person
Mehdi Rezaei
Street address
Velayat Ave., Nyaiesh Ave., No 115
City
Nasimshahr
Province
Tehran
Postal code
3766152624
Phone
+98 21 5675 9071
Email
mehdi.rezaei15@birjand.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Birjand
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
Mehdi Rezaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Velayat Ave., Nyaiesh Ave., No 115
City
Nasimshahr
Province
Tehran
Postal code
3766152624
Phone
+98 21 5675 9071
Email
mehdi.rezaei15@birjand.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
Mehdi Rezaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Velayat Ave., Nyaiesh Ave., No 115
City
Nasimshahr
Province
Tehran
Postal code
3766152624
Phone
+98 21 5675 9071
Email
Mehdi.rezaei15@birjand.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
Mehdi Rezaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Velayat Ave., Nyaiesh Ave., No 115
City
Nasimshahr
Province
Tehran
Postal code
3766152624
Phone
+98 21 5675 9071
Email
Mehdi.rezaei15@birjand.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The participant data file is confidential and only general information will be entered in the artic
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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