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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05435859
Other study ID # R01DC012379
Secondary ID R01DC012379
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 19, 2015
Est. completion date July 31, 2027

Study information

Verified date June 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Intracranial high-density electrodes make it possible to record neural activity directly from the brain surface with unparalleled spatial and temporal resolution to unravel both local and population encoding of speech sounds. This study proposes to assess speech perception in patients who are undergoing surgery for seizure localization or awake intraoperative brain mapping. Electrode placement is based on the clinical needs of each patient. The research study team will examine the mechanisms of phonetic encoding to reveal both the organization of auditory speech feature selectivity and the distributed population-level processing that give rise to the emergent properties of spoken language perception. The aims of this study seeks to determine the cortical encoding of phonological sequencing (Aim 1), representation of amplitude landmark coding in speech (Aim 2), and the shared and distinct mechanisms for speech and music melody encoding (Aim 3). Together, these aims will advance our understanding of speech encoding in the human brain beyond consonants and vowels, addressing questions pertaining to sequencing, amplitude coding, and auditory specialization. These results should heavily impact current theories of speech processing and, therefore, will have significant implications for understanding and remediating human language disorders.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date July 31, 2027
Est. primary completion date July 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speech Tasks
Listen to 25-minutes of speech sounds in English.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Deafness and Other Communication Disorders (NIDCD), University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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