Cortical Contributions to Frequency Following Responses and Modulation
2 other identifiers
interventional
73
1 country
1
Brief Summary
The frequency-following response (FFR), a scalp-recorded neurophonic potential, is a widely used metric of speech encoding integrity in healthy and clinical human populations. The translational potential of the FFR as a biomarker is constrained by poor understanding of its neural generators and influencing factors. This study leverages a cross-species and cross-level approach to provide mechanistic insight into the properties of the cortical source of the FFR, and elucidate the role of cortical feedback via cortico-collicular projections on modulation of the FFR as a function of stimulus context, arousal state, and category relevance. This clinical trial will focus on the influences of category relevance, predictability, and participant arousal state on the FFRs in neurotypical human participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2026
CompletedApril 24, 2026
April 1, 2026
4.1 years
July 30, 2021
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Pitch tracking and decoding accuracies for dynamically varying pitch in naturally produced Mandarin tone categories
The similarity between the stimulus and the FFR will be evaluated. The pitch tracking ability will be estimated by comparing the sliding window autocorrelation pitch tracks of the stimulus and FFR. Machine learning models will be trained to decode FFR to different stimulus categories based on pitch height and pitch direction. The chance estimates of the decoding accuracies will be estimated.
During EEG session, up to 3 hours
Stimulus-specific effects in Chinese vs. English participants
The stimulus-specific effects in human participants, based on pitch tracking and decoding accuracies, will be assessed. The decoding accuracies and pitch tracking metrics for mandarin tone categories will be compared between Chinese listeners and English listeners. The focus will be to evaluate the specific benefits in Chinese listeners to track pitch height and direction patterns in Mandarin tones.
During EEG session, up to 3 hours
Arousal state and predictability effects on the FFRs
Arousal state and its dependence on encoding of predictability effects on the FFRs will be evaluated. The pitch tracking metrics and decoding accuracies will be compared across repetitive and contextual stimulus sequences while sorting the trials based on peak pupillary dilation as a proxy for arousal state. The predictability effects will be charted as a function of the arousal states and evaluated.
During simultaneous EEG and pupillometry session, up to 3 hours
Study Arms (1)
Neurotypical Human Participants
EXPERIMENTALNative speakers of Chinese and native speakers of English
Interventions
Listening to repetitive and extended sound presentation induces specific neural and physiological activity that we will measure via electroencephalography and pupillometry
Eligibility Criteria
You may qualify if:
- Age 13 years up to 25 years
- Healthy volunteers
- Native English speaking individuals with no exposure or experience to tonal languages
- Native Mandarin speakers
- Hearing sensitivity within normal limits (Puretone hearing thresholds \< 25dB from 250
- Hz to 8000 Hz)
- Less than six years of formal music training or experience
You may not qualify if:
- Proficiency in languages other than English or Chinese
- History of or current complaint of hearing loss or tinnitus
- History of or current complaint of cognitive impairments
- Individuals with more than 5 years of formal music experience or training
- Complaints of impaired speech perception in noise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bharath Chandrasekaran, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 18, 2021
Study Start
January 20, 2022
Primary Completion
March 4, 2026
Study Completion
March 4, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will become available as soon as possible but no later than one year upon completion of the study
- Access Criteria
- Our data will be made publicly available as soon as possible online to make it easily and widely accessible.
We will follow the guidelines set forth by the Open Knowledge International, which is a global non-profit organization that advocates for open science and open data. Our objectives in data sharing are to provide free and open access to everyone. Consistent with ideas articulated in the Open Data Handbook (http://opendatahandbook.org/), we will apply for an open license for resources that are not deemed as intellectual properties, make data easily available in a format that is broadly accessible and ensures longevity, and advertise it on our webpages and via social media to make it discoverable.