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Pitch Perception and Memory: Deficits and Training (Pitch_Train)

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ClinicalTrials.gov Identifier: NCT03707691
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment Phase
Cochlear Implants Behavioral: Listening tests. Pitch training protocol Behavioral: visuo-spatial training protocol Behavioral: EEG/MEG/MRI recordings. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pitch Perception and Memory: Deficits and Training
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Rosin

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




Primary Outcome Measures :
  1. percentages of correct responses in listening tests [ Time Frame: during procedure ]
  2. reaction times in listening tests [ Time Frame: during procedure ]
  3. Event-Related Fields [ Time Frame: during procedure ]
    MEG measurements

  4. Oscillations [ Time Frame: during procedure ]
    MEG measurements


Secondary Outcome Measures :
  1. percentages of correct responses [ Time Frame: Day 0 ]
    Performance in listening tests in audio contexts

  2. percentages of correct responses [ Time Frame: Day 0 ]
    Performance in listening tests in audio-visual contexts

  3. reaction times [ Time Frame: Day 0 ]
    Performance in listening tests in audio contexts

  4. reaction times [ Time Frame: Day 0 ]
    Performance in listening tests in audio-visual contexts

  5. Event-Related Fields [ Time Frame: Day 0 ]
    EEG measurements

  6. Oscillations [ Time Frame: Day 0 ]
    EEG measurements



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT03707691


Contacts
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Contact: Anne CACLIN 4 72 13 89 04 ext +33 anne.caclin@inserm.fr
Contact: Barbara Tillmann 4 37 28 74 89 ext +33 barbara.tillmann@cnrs.fr

Locations
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France
Lyon Neuroscience Research Center Not yet recruiting
Bron, France, 69500
Contact: Anne CACLIN, PhD    4 72 13 89 04 ext +33    anne.caclin@inserm.fr   
Contact: Barbara Tillmann, PhD    4 37 28 74 89 ext +33    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         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Anne CACLIN Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03707691     History of Changes
Other Study ID Numbers: 69HCL18_0632
2018-A02670-55 ( Other Identifier: ID-RCB )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Hearing
Cochlear Implants
Congenital Amusia
Pitch
Audio-visual interactions