NCT05435859

Brief Summary

The basic mechanisms underlying comprehension of spoken language are still largely unknown. Over the past decade, the study team has gained new insights to how the human brain extracts the most fundamental linguistic elements (consonants and vowels) from a complex and highly variable acoustic signal. However, the next set of questions await pertaining to the sequencing of those auditory elements and how they are integrated with other features, such as, the amplitude envelope of speech. Further investigation of the cortical representation of speech sounds can likely shed light on these fundamental questions. Previous research has implicated the superior temporal cortex in the processing of speech sounds, but little is known about how these sounds are linked together into the perceptual experience of words and continuous speech. The overall goal is to determine how the brain extracts linguistic elements from a complex acoustic speech signal towards better understanding and remediating human language disorders.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Aug 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2022Jul 2027

First Submitted

Initial submission to the registry

June 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

June 22, 2022

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Electrocorticography (ECoG) Signals for Neural Activity Identified During Intraoperative Procedure or Inpatient Hospitalization

    Number of participants with ECoG signals for neural activity identified during intraoperative procedure or inpatient hospitalization, between 10-30 minutes.

    During Procedure

Study Arms (1)

Electrocorticography (ECoG) recording during Speech Tasks

EXPERIMENTAL

Participants listened to 25-minute Speech Tasks while ECoG signals for neural activity was recorded during their intraoperative procedure or inpatient hospitalization at the University of California, San Francisco (UCSF).

Behavioral: Speech Tasks

Interventions

Speech TasksBEHAVIORAL

Listen to 25-minutes of speech sounds in English.

Electrocorticography (ECoG) recording during Speech Tasks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with epilepsy or brain tumors at UCSF undergoing surgical electrode implantation for seizure localization or awake intraoperative brain mapping for resection of brain tumors or epilepsy and
  • Participants with electrodes implanted in at least two regions of interest who are willing and able to cooperate with study tasks.

You may not qualify if:

  • Participants who lack capacity or decline to provide informed consent,
  • Participants who have significant cerebral lesions or
  • Participants with cognitive deficits that preclude reliable completion of study tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

EpilepsyBrain NeoplasmsSpeech

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsVerbal BehaviorCommunicationBehavior

Study Officials

  • Edward F Chang, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 28, 2022

Study Start

August 16, 2022

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations