An interventional study of Speech and non-speech sound stimulation in Language, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 13 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Northwestern University · Not applicable, Interventional, and Basic science
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.
Participants will listen to a variety of sounds while the frequency-following response (FFR) is recorded. The FFR is a sound-evoked response that mirrors the acoustic properties of the incoming acoustic signal with remarkable fidelity. The FFR is now recognized as an integrated response resulting from an interplay of early auditory subcortical and cortical systems. The cortical dynamics underlying the FFR are unclear. All stimuli will be normalized to the same root mean squared amplitude and stimulus duration and played at the same in-the-ear intensity. Thirty-two stimuli from human and animal natural productions with a wide-range of F0 will be used to elicit the FFR. At least 1000 artifact-free trials will be collected for every stimulus. Participants will sit in a quiet room (patients) or a sound-treated booth and listen to sounds while electroencephalography (EEG) and pupillometry signals are continuously acquired. EEG signals will be collected using Ag-AgCl scalp electrodes, with the active electrode placed at the central zero (Cz) point, the reference at the right mastoid, and the ground at the left mastoid. Contact impedence will be\< 5 kΩ for all electrodes for all recording sessions, and responses will be recorded at a sampling rate of 25 kHz using Brain Vision PyCorder 1.0.7 (Brain Products, Gilching, Germany). Alternating polarities of the stimuli will be binaurally presented in sound field (identical to the animal protocols), with an inter-stimulus interval jittered between 122 to 148ms. Participants will be instructed to stay awake and refrain from making extraneous movements. EEG and pupil measures will allow continuous monitoring of participant state. The order of blocks will be counterbalanced across participants, and stimulus presentation will be controlled by E-Prime 2.0.10 software. The electrophysiological data will be preprocessed with BrainVision Analyzer 2.0 (Brain Products, Gilching, Germany), bandpass filtered (varies based on stimulus F0; 12 dB/octave, zero phase-shift). The bandpass filter will approximately reflect the lower and upper limits of phase-locking along the auditory pathway that contributes to the FFR (auditory cortex, midbrain). Responses will be segmented into epochs, baseline corrected to the mean voltage of the noise floor(-40 to 0ms). Epochs in which the amplitude exceeds ± 35μV will be considered artifacts and rejected. In each session, a preset number of artifact-free FFR trials (500 for each polarity) will be obtained. For pupillometry, participants will be seated in a chair and will place their head on a chin rest. The stabilized mount also has a small horizontal bar that they can place their forehead against. To calibrate the eye tracker, participants will be asked to follow 9 dots that appear on a monitor with their eyes. Insert earbuds will be placed in both ears, and auditory stimuli will be presented binaurally. Pupillometry data will be preprocessed to remove noise from the analysis. The pupil data will be downsampled to 50 Hz. Trials with more than 15% of the samples detected as blinks will be removed. Missing samples due to blinks will be linearly interpolated from approximately100 ms prior to and 100 ms after the blink. Pupil responses will be baseline normalized using the average pupil size in the 500-1000 ms prior to the onset of the auditory stimuli. A key variable reported will be the percent change in pupil size.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's enrollment of 73 is above the median of 65 across 158 interventional studies indexed under Language.
Browse Language studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Native speakers of Chinese and native speakers of English
Behavioral: Speech and non-speech sound stimulation
Listening to repetitive and extended sound presentation induces specific neural and physiological activity that we will measure via electroencephalography and pupillometry
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.
Time frame: 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.
Time frame: 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.
Time frame: During simultaneous EEG and pupillometry session, up to 3 hours
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, 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.
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Mar 2026, 49 months.
Of 89 non-industry interventional studies with no phase under Language, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's 49 months is above that.
Counting every sponsor, half of 93 studies reached it within 33 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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