NCT04290130

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress99%
Sep 2019May 2026

Study Start

First participant enrolled

September 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

6.7 years

First QC Date

February 25, 2020

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of neural activity

    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.

Interventions

We will present audiovisual speech and record neural responses.

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be undergoing neurosurgery for the treatment of a brain disorder

You may not qualify if:

  • must have corrected-to-normal vision and hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

February 25, 2020

First Posted

February 28, 2020

Study Start

September 15, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations