Cortical Contributions to FFR: Post-Op Outcomes
Cortical Contributions to Frequency-Following Response Generation and Modulation; Post-Operative Outcomes
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
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
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedStudy Start
First participant enrolled
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
January 15, 2026
January 1, 2026
3.9 years
January 12, 2022
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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.
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.
During follow-up research sessions, at least 6-months post-sEEG
Study Arms (1)
Neurosurgical Patients
EXPERIMENTALPatient participants with previously excised tissue within Heschl's gyrus (as dictated by clinical care)
Interventions
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
Eligibility Criteria
You may qualify if:
- Individuals 13-25 years old
- Undergoing medically necessary surgical resection of Heschl's gyrus lesion
- Monolingual English speakers
- Receptive and expressive language within normal limits
- Normal or corrected-to-normal visual acuity
- Normal hearing acuity in each ear (as determined during an audiometric assessment)
- Nonverbal IQ within normal limits
- No history of autism spectrum disorder or attention-deficit hyperactivity disorder
You may not qualify if:
- Significant medical or neuropsychological impairment that would result in the patient being unable to participate in study activities
- History of autism or ADHD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Related Publications (3)
Arehart KH, Kates JM, Anderson MC. Effects of noise, nonlinear processing, and linear filtering on perceived music quality. Int J Audiol. 2011 Mar;50(3):177-90. doi: 10.3109/14992027.2010.539273.
PMID: 21319935BACKGROUNDCoffey EBJ, Nicol T, White-Schwoch T, Chandrasekaran B, Krizman J, Skoe E, Zatorre RJ, Kraus N. Evolving perspectives on the sources of the frequency-following response. Nat Commun. 2019 Nov 6;10(1):5036. doi: 10.1038/s41467-019-13003-w.
PMID: 31695046BACKGROUNDWhite-Schwoch T, Anderson S, Krizman J, Nicol T, Kraus N. Case studies in neuroscience: subcortical origins of the frequency-following response. J Neurophysiol. 2019 Aug 1;122(2):844-848. doi: 10.1152/jn.00112.2019. Epub 2019 Jul 3.
PMID: 31268800BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taylor Abel, MD
University of Pittsburgh
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
- Assistant Professor
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 28, 2022
Study Start
February 14, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2030
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.