An interventional study of Speech sound stimulation in Language, sponsored by University of Pittsburgh. Enrolling by invitation at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science
The purpose of this study is to better understand cortical contributions of the human temporal lobe to the frequency-following response. Frequency-following responses (FFR) are electrophysiological recordings that reflect phase-locked activity of neural ensembles in the auditory pathway and are used as an indicator of the integrity of supra-threshold speech processing. FFR was first studied in subcortical areas, but recent consensus in the literature supports the notion that it is an integrated response between subcortical and cortical neural populations. The proposed study aims to deconstruct the role of the cortex in generating and modulating the FFR. The research team will build a novel computational model of FFR mechanisms and use EEG recordings from participants who have undergone resection of lesions in Heschl's gyrus to validate model predictions.
The purpose of this study is to better understand the cortical contribution of the human temporal lobe to the generation and modulation of frequency-following responses (FFR).
The specific aims of this study is as follows:
The hypothesis to be tested for the previously listed purposes and aims are as follows:
1. When cortical areas involved in generating and modulating the FFR, in this case Heschl's gyrus, are removed or inactivated, the FFR response will be attenuated.
The frequency-following response has been used extensively in auditory processing literature as a minimally invasive method of recording the integrity of supra-threshold speech processing. It was once considered to be reflective of only subcortical activity in structures like the brainstem, however a recent consensus has been reached in research on the topic that supports the notion of cortical neural population involvement in FFR as well.
The pilot study conducted under the initial parent grant for this study (Online Modulation of Auditory Brainstem Responses to Speech) proposed that subcortical auditory processing is not a hard-wired mechanism in the human brain but is rather continuously fine-tuned to stimuli by top-down expectations. This study further demonstrated that stimulus predictability, attention, and category-relevance have a robust effect on response fidelity and can modulate the FFR. The current study proposes to study the same effects and response patterns in cortical structures. Limited studies to date have investigated the effect of auditory cortex lesions on the FFR and existing studies did not account for the variables investigated in this study that are proposed to have a significant effect on modulation of FFRs.
Even though FFR is widely accepted as a metric for measuring the integrity of speech encoding, there remains a poor understanding of the neural generators of this response. A few studies to date have already identified abnormal or dysfunctional FFR in certain clinical populations like ADHD and autism spectrum disorders. The proposed study additionally seeks to identify the potential translational utility of FFR as a biomarker for clinical conditions.
This study is innovative as data from this study will allow researchers to build a novel computational model of cortical feedforward and feedback mechanisms, which will be tested in patient participants who have undergone surgical resection of Heschl's gyrus lesions.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's planned enrollment of 10 is below the median of 65 across 158 interventional studies indexed under Language.
Browse Language studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Patient participants with previously excised tissue within Heschl's gyrus (as dictated by clinical care)
Behavioral: Speech sound stimulation
Participants will listen to repetitive speech sound stimuli, presented through headphones, which will induce a neural response (frequency-following response) to be measured via electroencephalography and pupillometry
Pitch Decoding Accuracy
Pitch decoding accuracy will be measured as a stimulus-to-response correlation between stimulus pitch (in Hz) and scalp-recorded frequency-following responses (FFR). Hidden Markov models (HMMs) will be used to decode stimulus identity information from recorded FFRs.
Time frame: During sEEG-EEG recording sessions, up to 3 hours total
Frequency-Following Response Magnitude
The frequency-following response magnitude will be measured by analyzing the time-domain averaged spectral peak of scalp-recorded FFRs.
Time frame: During sEEG-EEG recording sessions, up to 3 hours total
Cortical Phase-Locking Limits of Frequency-Following Response
Phase-locking limits of FFRs will be measured by comparing phase coherence of stimulus waveforms and scalp-recorded FFRs. The phase-locking limit will be determined as a function of dependence on stimulus frequency.
Time frame: During sEEG-EEG recording sessions, up to 3 hours total
Predictability Effects of Cortical Resection on Pitch Decoding Accuracy
The predictability effects of cortical resection on pitch decoding accuracy will be measured via comparison of decoding accuracies obtained in Outcome 1 and values predicted by a previously created computational model of frequency-following response constrained by data from neurotypical participants.
Time frame: During follow-up research sessions, at least 6-months post-sEEG
Predictability Effects of Cortical Resection on Frequency-Following Response Magnitude
The predictability effects of cortical resection on frequency-following response magnitude will be measured via comparison of response magnitude measurements obtained in Outcome 3 and values predicted by a previously created computational model of frequency-following response constrained by data from neurotypical participants.
Time frame: During follow-up research sessions, at least 6-months post-sEEG
Predictability Effects of Cortical Resection on Phase-Locking Limits of Frequency-Following Response
The predictability effects of cortical resection on phase-locking limits of the frequency-following response will be measured via comparison of phase-locking limits obtained in Outcome 3 and values predicted by a previously created computational model of frequency-following response constrained by data from neurotypical participants.
Time frame: During follow-up research sessions, at least 6-months post-sEEG
Plan to share: Yes — The individual deidentified participant data intended to be shared include the individual participant data that underlie the results to be reported in published articles after deidentification. Other documents that will be available include the study protocol, statistical analysis plan, and analytic code. Data will be available as soon as possible following publication, but no later than one year upon completion. There is no end date. IPD will be made available for any purpose via open access.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be made 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 online as soon as possible. Data will be easily and widely accessible.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.