Effects of the Combination of RRT With tDCS on Dyslexic Adults

• ClinicalTrials.gov Identifier: NCT03119402
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: January 25, 2018
• Sponsor: Catholic University of the Sacred Heart
• Information provided by (Responsible Party): Alice Cancer, Catholic University of the Sacred Heart

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.

Condition or disease	Intervention/treatment	Phase
Developmental Dyslexia	Behavioral: Rhythmic Reading Training; Device: Transcranial direct current stimulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Participants are prevented from having knowledge of which experimental condition (active or sham tDCS) they are assigned to.
• Primary Purpose: Treatment
• Official Title: Combining A Rhythmic Intervention With tDCS to Improve Reading Skills in Dyslexic Adults
• Actual Study Start Date: April 18, 2017
• Actual Primary Completion Date: September 4, 2017
• Estimated Study Completion Date: April 4, 2018

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: tDCS

Outcome Measures

Primary Outcome Measures :

1. Text reading speed expressed in syllables per seconds [ Time Frame: 2 weeks ]
   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. Text reading accuracy expressed in number of errors [ Time Frame: 2 weeks ]
   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.
3. Word reading speed expressed in syllables per seconds [ Time Frame: 2 weeks ]
   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).
4. Word reading accuracy expressed in number of errors [ Time Frame: 2 weeks ]
   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).
5. Pseudo-word reading speed expressed in syllables per seconds [ Time Frame: 2 weeks ]
   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).
6. Pseudo-word reading accuracy expressed in number of errors [ Time Frame: 2 weeks ]
   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 :

1. Rapid Automatized Naming [ Time Frame: 2 weeks ]
   Rapid Automatized Naming of colours and figures
2. Verbal Working Memory [ Time Frame: 2 weeks ]
   Onwards and backwards digit span
3. Rhythm Discrimination [ Time Frame: 2 weeks ]
   Rhythm discrimination task

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Alice Cancer, MD; 00390272342284; alice.cancer@unicatt.it

Contact: Alessandro Antonietti, PhD; alessandro.antoniett@unicatt.it

Locations

Italy

Catholic University of the Sacred Heart; Recruiting

Milan, Italy, 20123

Contact: Alice Cancer, MD alice.cancer@unicatt.it

Sponsors and Collaborators

Catholic University of the Sacred Heart

More Information

• Responsible Party: Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart
• ClinicalTrials.gov Identifier: NCT03119402
• Other Study ID Numbers: RRT+tDCS
• First Posted: April 18, 2017
• Last Update Posted: January 25, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Alice Cancer, Catholic University of the Sacred Heart:

Reading; Developmental Dyslexia; Music; Rhythm; transcranial electrical stimulation; transcranial direct current stimulation

Additional relevant MeSH terms:

Dyslexia; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disorders; Neurodevelopmental Disorders; Mental Disorders