Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years (RnDys)

February 28, 2025 updated by: Institut Pasteur
Studies of dyslexia have shown altered oscillatory activity in the low gamma band (~25-35 Hz) in the left auditory cortex. Neural oscillations around 30 Hz constitute the basic sampling rate of speech, from which the ability to form specific phonemic categories on which reading learning is based is derived. An alteration of the oscillatory activity at 30 Hz could therefore influence the ability of children to learn to read, and explain the reading deficit observed in children with a specific written language disorder. The objective of our study is to determine whether intensive rhythmic auditory stimulation applied during 30 sessions of 15 minutes spread over 6 weeks (5 sessions per week) can correct neural oscillations in the gamma-low band, allowing an improvement of phonemic categorization abilities, and thus the reading abilities of dyslexic readers aged 7 to 9 years. The long-term objective of this study is to test the therapeutic potential of auditory stimulation with speech rhythms for the treatment of reading disorders.

Study Overview

Detailed Description

Longitudinal cross-over study carried out on 4 experimental groups to compare the effect of two rhythmic auditory trainings (30 Hz and low frequencies) compared to the effect of a grapho-phonological correspondence training (GraphoGame).

The study begins with a recruitment and inclusion period after diagnosis of dyslexia. During this study, 4 assessments are performed and include behavioral measures in the care setting and electrophysiological measures in the research setting:

  • at time T1 before any remediation,
  • at T2 after the first training,
  • at T3 at most 7 days after the 2nd training session,
  • at T4 seven weeks after T3.

After the T1 assessment, participants were randomized into 4 different groups (training 1 then training 2):

Group 1 : Auditory Rhythmic at 30 Hz then GraphoGame Group 2 : GraphoGame then Rhythmic Auditory at 30 Hz Group 3 : Auditory Rhythmic at low frequencies then GraphoGame Group 4 : GraphoGame then Auditory Low Frequency Rhythmic The first training period (total duration 6 weeks) according to the assigned group begins and takes place at the speech therapist's office and at home.

After the T2 evaluation, the 2nd training period (total duration 6 weeks) according to the assigned group begins and takes place at the SLP's office as well as at home.

The post-training evaluations T3 and T4 take place, respectively, 1 week and 7 weeks after the last training.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Paris, France
        • Recruiting
        • Institut de l'Audition
        • Contact:
          • Diane Lazard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • between 7 and 9 years old
  • in regular schooling
  • have a diagnosis of dyslexia
  • have a non-verbal intelligence assessment within the norm. Inclusion assessments must show a major reading disability without associated cognitive deficits.
  • be equipped with a PC at home
  • have given their assent and whose parents/legal guardians have given their oral consent

Exclusion Criteria:

  • have any other diagnosis of language impairment
  • have a neurological disorder (visual, auditory, executive)
  • have an associated psychiatric disorder
  • have a developmental delay.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Auditory Rhythmic at 30 Hz then GraphoGame
Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)
behavioral measures
Electrophysiological measures
Training 1
Training 2
Other: GraphoGame then Rhythmic Auditory at 30 Hz
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)
behavioral measures
Electrophysiological measures
Training 1
Training 2
Other: Auditory Rhythmic at low frequencies then GraphoGame
Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)
behavioral measures
Electrophysiological measures
Training 1
Training 2
Other: GraphoGame then Auditory Low Frequency Rhythmic
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)
behavioral measures
Electrophysiological measures
Training 1
Training 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Time Frame: 2 years
Comparison of reading performance is assessed in terms of both accuracy and speed. High percentage of correct responses means that children improve their reading accuracy.
2 years
Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Time Frame: 2 years
Comparison of reading performance is assessed in terms of both accuracy and speed. A short time means that children improve their reading speed.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
Time Frame: 2 years
Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
2 years
Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
Time Frame: 2 years
Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Diane Lazard, MD, Institut Pasteur
  • Study Director: Anne-Lise Giraud, PhD, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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