- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04290130
Dynamic Neural Mechanisms of Audiovisual Speech Perception
October 9, 2023 updated by: Michael Beauchamp, PhD, University of Pennsylvania
Understanding speech is one of the most important functions of the human brain.
We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech.
We will use intracranial encephalography to study the organization and operation of the brain during audiovisual speech perception.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- must be undergoing neurosurgery for the treatment of a brain disorder
Exclusion Criteria:
- must have corrected-to-normal vision and hearing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of neural activity
Time Frame: During the procedure.
|
The name of the measurement is the broadband high-frequency activity (BHA) in the brain in response to audiovisual speech.
The unit of measure is % increase in power from pre-stimulus baseline.
The name of the measurement tool is intracranial EEG, recordings of the raw voltage signal from each electrode implanted in the brain.
The voltage-by-time signal will be converted to spectral space using a wavelet transform, and the magnitude of the power between 70 and 150 Hz inclusive in a time window between 0 ms and 500 ms after stimulus onset will be calculated.
|
During the procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
May 31, 2024
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 9, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 844668
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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