NCT05010473

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

July 30, 2021

Last Update Submit

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

EXPERIMENTAL

Native speakers of Chinese and native speakers of English

Behavioral: Speech and non-speech sound stimulation

Interventions

Listening to repetitive and extended sound presentation induces specific neural and physiological activity that we will measure via electroencephalography and pupillometry

Neurotypical Human Participants

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Bharath Chandrasekaran, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations