Effects of the Combination of RRT With tDCS on Dyslexic Adults

NCT03119402 | Unknown

• 1 other identifier: RRT+tDCS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dyslexia

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Rapid Automatized Naming

  2 weeks

• Verbal Working Memory

  2 weeks

• Rhythm Discrimination

  2 weeks

Study Arms (2)

RRT + active tDCS

EXPERIMENTAL

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; Device: Transcranial direct current stimulation

RRT + sham tDCS

SHAM COMPARATOR

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; Device: Transcranial direct current stimulation

Interventions

Rhythmic Reading Training BEHAVIORAL

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.

Also known as: RRT

RRT + active tDCS; RRT + sham tDCS

Transcranial direct current stimulation DEVICE

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.

Also known as: tDCS

RRT + active tDCS; RRT + sham tDCS

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Milan, 20123, Italy

RECRUITING

MeSH Terms

Conditions

Dyslexia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Alice Cancer, MD

CONTACT

00390272342284; alice.cancer@unicatt.it

Alessandro Antonietti, PhD

CONTACT

alessandro.antoniett@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are prevented from having knowledge of which experimental condition (active or sham tDCS) they are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 18, 2017
• Study Start: April 18, 2017
• Primary Completion: September 4, 2017
• Study Completion: April 4, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

IT (1)