Pitch Perception and Memory: Deficits and Training

Cochlear Implants Clinical Trial

— Pitch_Train  

Official title:

Pitch Perception and Memory: Deficits and Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03707691
• Other study ID #: 69HCL18_0632
• Secondary ID: 2018-A02670-55
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 26, 2025

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Anne CACLIN
• Phone: 4 72 13 89 04
• Email: anne.caclin[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: October 26, 2025
• Est. primary completion date: October 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

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.
• 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.
• EEG/MEG/MRI recordings.
Listening tests. EEG/MEG/MRI recordings

Locations

Country	Name	City	State
France	Lyon Neuroscience Research Center	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentages of correct responses in listening tests		during procedure
Primary	reaction times in listening tests		during procedure
Primary	Event-Related Fields	MEG measurements	during procedure
Primary	Oscillations	MEG measurements	during procedure
Secondary	percentages of correct responses	Performance in listening tests in audio contexts	Day 0
Secondary	percentages of correct responses	Performance in listening tests in audio-visual contexts	Day 0
Secondary	reaction times	Performance in listening tests in audio contexts	Day 0
Secondary	reaction times	Performance in listening tests in audio-visual contexts	Day 0
Secondary	Event-Related Fields	EEG measurements	Day 0
Secondary	Oscillations	EEG measurements	Day 0