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Trial record 10 of 49 for:    "Dyslexia"

Effects of the Combination of RRT With tDCS on Dyslexic Adults

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

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 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

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




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



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119402


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

Responsible Party: Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03119402     History of Changes
Other Study ID Numbers: RRT+tDCS
First Posted: April 18, 2017    Key Record Dates
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
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders