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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

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date October 16, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • percentages of correct responses in listening tests [ Time Frame: during procedure ]
  • reaction times in listening tests [ Time Frame: during procedure ]
  • Event-Related Fields [ Time Frame: during procedure ]
    MEG measurements
  • Oscillations [ Time Frame: during procedure ]
    MEG measurements
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • percentages of correct responses [ Time Frame: Day 0 ]
    Performance in listening tests in audio contexts
  • percentages of correct responses [ Time Frame: Day 0 ]
    Performance in listening tests in audio-visual contexts
  • reaction times [ Time Frame: Day 0 ]
    Performance in listening tests in audio contexts
  • reaction times [ Time Frame: Day 0 ]
    Performance in listening tests in audio-visual contexts
  • Event-Related Fields [ Time Frame: Day 0 ]
    EEG measurements
  • Oscillations [ Time Frame: Day 0 ]
    EEG measurements
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pitch Perception and Memory: Deficits and Training
Official Title  ICMJE Pitch Perception and Memory: Deficits and Training
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cochlear Implants
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cochlear implant users
    In both arms a pitch training protocol and a visuo-spatial training protocol are applied.
    Interventions:
    • Behavioral: Listening tests. Pitch training protocol
    • Behavioral: visuo-spatial training protocol
    • Behavioral: EEG/MEG/MRI recordings.
  • Experimental: Participants with Congenital Amusia
    In both arms a pitch training protocol and a visuo-spatial training protocol are applied.
    Interventions:
    • Behavioral: Listening tests. Pitch training protocol
    • Behavioral: visuo-spatial training protocol
    • Behavioral: EEG/MEG/MRI recordings.
  • Experimental: Control Participants
    Interventions:
    • Behavioral: Listening tests. Pitch training protocol
    • Behavioral: visuo-spatial training protocol
    • Behavioral: EEG/MEG/MRI recordings.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2018)
670
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03707691
Other Study ID Numbers  ICMJE 69HCL18_0632
2018-A02670-55 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne CACLIN Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP