Pitch Perception and Memory: Deficits and Training (Pitch_Train)

Pitch perception and memory are central in auditory cognition, in particular for sound source segregation and recognition, speech prosody and music processing. Here the investigator assess pitch perception and memory in hearing-impaired listeners wearing cochlear implant(s) and listeners with congenital amusia, both compared with control listeners. Behavioral, EEG, and MEG measures are collected in audio and audio-visual contexts to characterize pitch processing deficits, and test a pitch training program.

Study Overview

• Status: Recruiting
• Conditions: Cochlear Implants
• Intervention / Treatment: Behavioral: Listening tests. Pitch training protocol; Behavioral: visuo-spatial training protocol; Behavioral: EEG/MEG/MRI recordings.

• Study Type: Interventional
• Enrollment (Estimated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne CACLIN; Phone Number: +33 4 72 13 89 04; Email: anne.caclin@inserm.fr
• Study Contact Backup: Name: Barbara Tillmann; Phone Number: +33 4 37 28 74 89; Email: barbara.tillmann@cnrs.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Lyon Neuroscience Research Center
    • Contact: Anne CACLIN, PhD; Phone Number: +33 4 72 13 89 04; Email: anne.caclin@inserm.fr
    • Contact: Barbara Tillmann, PhD; Phone Number: +33 4 37 28 74 89; Email: barbara.tillmann@cnrs.fr
    • Principal Investigator: Anne CACLIN, PhD
    • Sub-Investigator: Barbara Tillmann, PhD
    • Sub-Investigator: Aurélie BIDET-CAULET, PhD
    • Sub-Investigator: Annie MOULIN, PhD
    • Sub-Investigator: Eric TRUY, MD, PhD
    • Sub-Investigator: Ruben HERMANN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For adult participants:

• Aged between 18 and 90
• Absence of neurological and psychiatric disorders
• No major cognitive deficit, ability to understand and apply study instructions
• Motivation to participate efficiently in the study
• Written informed consent to participant in the study
• Affiliated to social security
• Control participants and participants with congenital amusia for Experiment 5: MRI/MEG compatibility

For underage participants:

• Subject aged 5 years and over
• Informed consent of parents or guardians for the participation of the child being studied
• No neurological or psychiatric history
• Without major cognitive impairment and ability to understand and apply setpoint.
• Subject affiliated to a social security scheme
• Motivation to participate effectively in the project

Exclusion Criteria:

For adult participants:

• Age below 18 or above 90
• Pregnant or breast-feeding woman

For underage participants:

- Pregnant or nursing minors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cochlear implant users; In both arms a pitch training protocol and a visuo-spatial training protocol are applied.	Behavioral: Listening tests. Pitch training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: visuo-spatial training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: EEG/MEG/MRI recordings.; Listening tests. EEG/MEG/MRI recordings
Experimental: Participants with Congenital Amusia; In both arms a pitch training protocol and a visuo-spatial training protocol are applied.	Behavioral: Listening tests. Pitch training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: visuo-spatial training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: EEG/MEG/MRI recordings.; Listening tests. EEG/MEG/MRI recordings
Experimental: Control Participants	Behavioral: Listening tests. Pitch training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: visuo-spatial training protocol; The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.; Behavioral: EEG/MEG/MRI recordings.; Listening tests. EEG/MEG/MRI recordings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentages of correct responses in listening tests		during procedure
reaction times in listening tests		during procedure
Event-Related Fields	MEG measurements	during procedure
Oscillations	MEG measurements	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentages of correct responses	Performance in listening tests in audio contexts	Day 0
percentages of correct responses	Performance in listening tests in audio-visual contexts	Day 0
reaction times	Performance in listening tests in audio contexts	Day 0
reaction times	Performance in listening tests in audio-visual contexts	Day 0
Event-Related Fields	EEG measurements	Day 0
Oscillations	EEG measurements	Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Anne CACLIN, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Estimated): October 26, 2025
• Study Completion (Estimated): October 26, 2025

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hearing; Cochlear Implants; Congenital Amusia; Pitch; Audio-visual interactions
• Other Study ID Numbers: 69HCL18_0632; 2018-A02670-55 (Other Identifier: ID-RCB)

Drug and device information, study documents

• 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