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

NCT05996497 | Recruiting

• 2 other identifiers: 2022-0632022-A01132-41
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslexia

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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 Outcomes (2)

• Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.

  2 years

• Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.

  2 years

Study Arms (4)

Auditory Rhythmic at 30 Hz then GraphoGame

OTHER

Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)

Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2

GraphoGame then Rhythmic Auditory at 30 Hz

OTHER

Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)

Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2

Auditory Rhythmic at low frequencies then GraphoGame

OTHER

Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)

Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2

GraphoGame then Auditory Low Frequency Rhythmic

OTHER

Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)

Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2

Interventions

behavioral measures BEHAVIORAL

behavioral measures

Auditory Rhythmic at 30 Hz then GraphoGame; Auditory Rhythmic at low frequencies then GraphoGame; GraphoGame then Auditory Low Frequency Rhythmic; GraphoGame then Rhythmic Auditory at 30 Hz

Electrophysiological measures OTHER

Electrophysiological measures

Auditory Rhythmic at 30 Hz then GraphoGame; Auditory Rhythmic at low frequencies then GraphoGame; GraphoGame then Auditory Low Frequency Rhythmic; GraphoGame then Rhythmic Auditory at 30 Hz

Training 1 OTHER

Training 1

Auditory Rhythmic at 30 Hz then GraphoGame; Auditory Rhythmic at low frequencies then GraphoGame; GraphoGame then Auditory Low Frequency Rhythmic; GraphoGame then Rhythmic Auditory at 30 Hz

Training 2 OTHER

Training 2

Auditory Rhythmic at 30 Hz then GraphoGame; Auditory Rhythmic at low frequencies then GraphoGame; GraphoGame then Auditory Low Frequency Rhythmic; GraphoGame then Rhythmic Auditory at 30 Hz

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between 7 and 9 years old
• in regular schooling
• have a diagnosis of dyslexia
• be equipped with a PC at home
• have given their assent and whose parents/legal guardians have given their oral consent

You may not qualify if:

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

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut de l'Audition: collaborator

Study Sites (1)

Institut de l'Audition

Paris, France

RECRUITING

MeSH Terms

Conditions

Dyslexia

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

Study Officials

• Diane Lazard, MD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Anne-Lise Giraud, PhD

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Sophie Bouton, PhD

CONTACT

sophie.bouton@pasteur.fr

Anne-Lise Giraud, PhD

CONTACT

+33176535054; anne-lise.giraud-mamessier@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 18, 2023
• Study Start: October 5, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

FR (1)