Effects of the Combination of RRT With tDCS on Dyslexic Adults

Developmental Dyslexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03119402
• Other study ID #: RRT+tDCS
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2017
• Last updated: January 23, 2018
• Start date: April 18, 2017
• Est. completion date: April 4, 2018

Study information

• Verified date: January 2018
• Source: Catholic University of the Sacred Heart
• Contact: Alice Cancer, MD
• Phone: 00390272342284
• Email: alice.cancer[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 4, 2018
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Rapid Automatized Naming	Rapid Automatized Naming of colours and figures	2 weeks
Secondary	Verbal Working Memory	Onwards and backwards digit span	2 weeks
Secondary	Rhythm Discrimination	Rhythm discrimination task	2 weeks