Back to resultsEffects of the Combination of RRT With tDCS on Dyslexic Adults
Primary Purpose
Developmental Dyslexia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rhythmic Reading Training
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Dyslexia focused on measuring Reading, Developmental Dyslexia, Music, Rhythm, transcranial electrical stimulation, transcranial direct current stimulation
Eligibility Criteria
Inclusion Criteria:
- having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice
Exclusion Criteria:
- presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
- exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).
Sites / Locations
- Catholic University of the Sacred HeartRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
RRT + active tDCS
RRT + sham tDCS
Arm Description
Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of active tDCS (1.5 mA, 5x5cm anodal electrode on left parieto-temporal regions and 5x5cm cathodal electrode on right parieto-temporal regions).
Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of sham tDCS (with the same active tDCS setup, current applied for 30 seconds,
Outcomes
Primary Outcome Measures
Text reading speed expressed in syllables per seconds
The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.
Text reading accuracy expressed in number of errors
The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.
Word reading speed expressed in syllables per seconds
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Word reading accuracy expressed in number of errors
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Pseudo-word reading speed expressed in syllables per seconds
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Pseudo-word reading accuracy expressed in number of errors
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Secondary Outcome Measures
Rapid Automatized Naming
Rapid Automatized Naming of colours and figures
Verbal Working Memory
Onwards and backwards digit span
Rhythm Discrimination
Rhythm discrimination task
Full Information
NCT ID
NCT03119402
First Posted
April 6, 2017
Last Updated
January 23, 2018
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT03119402
Brief Title
Effects of the Combination of RRT With tDCS on Dyslexic Adults
Official Title
Combining A Rhythmic Intervention With tDCS to Improve Reading Skills in Dyslexic Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
April 4, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS) on reading abilities of a group of Italian undergraduate students with dyslexia. Two experimental conditions (active vs. sham) will be compared. Finally, the effects of the intervention on other cognitive functions involved in the process of reading (i.e., rapid automatized naming, verbal working memory, rhythm perception abilities) will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
Keywords
Reading, Developmental Dyslexia, Music, Rhythm, transcranial electrical stimulation, transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are prevented from having knowledge of which experimental condition (active or sham tDCS) they are assigned to.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RRT + active tDCS
Arm Type
Experimental
Arm Description
Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of active tDCS (1.5 mA, 5x5cm anodal electrode on left parieto-temporal regions and 5x5cm cathodal electrode on right parieto-temporal regions).
Arm Title
RRT + sham tDCS
Arm Type
Sham Comparator
Arm Description
Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of sham tDCS (with the same active tDCS setup, current applied for 30 seconds,
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic Reading Training
Other Intervention Name(s)
RRT
Intervention Description
RRT is a computerized reading training program designed for Italian students with dyslexia. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
tDCS (transcranial direct current stimulation) is a noninvasive weak-current brain stimulation technique that can facilitate (anodal electrode) or inhibit (cathodal electrode) cortical activity, thus offering exciting possibilities for the enhancement and treatment of impaired cognitive abilities.
Primary Outcome Measure Information:
Title
Text reading speed expressed in syllables per seconds
Description
The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
2 weeks
Title
Text reading accuracy expressed in number of errors
Description
The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
2 weeks
Title
Word reading speed expressed in syllables per seconds
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
2 weeks
Title
Word reading accuracy expressed in number of errors
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
2 weeks
Title
Pseudo-word reading speed expressed in syllables per seconds
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
2 weeks
Title
Pseudo-word reading accuracy expressed in number of errors
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Rapid Automatized Naming
Description
Rapid Automatized Naming of colours and figures
Time Frame
2 weeks
Title
Verbal Working Memory
Description
Onwards and backwards digit span
Time Frame
2 weeks
Title
Rhythm Discrimination
Description
Rhythm discrimination task
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice
Exclusion Criteria:
presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Cancer, MD
Phone
00390272342284
Email
alice.cancer@unicatt.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Antonietti, PhD
Email
alessandro.antoniett@unicatt.it
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Milan
ZIP/Postal Code
20123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Cancer, MD
Email
alice.cancer@unicatt.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of the Combination of RRT With tDCS on Dyslexic Adults
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