Effects of the Combination of RRT With tDCS on Dyslexic Adults

Combining A Rhythmic Intervention With tDCS to Improve Reading Skills in Dyslexic Adults

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.

Study Overview

• Status: Unknown
• Conditions: Developmental Dyslexia
• Intervention / Treatment: Behavioral: Rhythmic Reading Training; Device: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Cancer, MD; Phone Number: 00390272342284; Email: alice.cancer@unicatt.it
• Study Contact Backup: Name: Alessandro Antonietti, PhD; Email: alessandro.antoniett@unicatt.it

Study Locations

• Italy
  • Milan, Italy, 20123
    • Recruiting
    • Catholic University of the Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RRT + active tDCS; 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).	Behavioral: Rhythmic Reading Training; 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.; Other Names: RRT; Device: Transcranial direct current stimulation; 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.; Other Names: tDCS
SHAM_COMPARATOR: RRT + sham tDCS; 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,	Behavioral: Rhythmic Reading Training; 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.; Other Names: RRT; Device: Transcranial direct current stimulation; 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.; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	2 weeks
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).	2 weeks
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).	2 weeks
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).	2 weeks
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).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapid Automatized Naming	Rapid Automatized Naming of colours and figures	2 weeks
Verbal Working Memory	Onwards and backwards digit span	2 weeks
Rhythm Discrimination	Rhythm discrimination task	2 weeks

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2017
• Primary Completion (ACTUAL): September 4, 2017
• Study Completion (ANTICIPATED): April 4, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; Reading; Music; transcranial electrical stimulation; Developmental Dyslexia; Rhythm
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: RRT+tDCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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