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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181149
Other study ID # R01DC020162
Secondary ID 1R01DC020162-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 30, 2027

Study information

Verified date January 2024
Source Arizona State University
Contact Ayoub Daliri, PhD
Phone 4807278397
Email ayoub.daliri@asu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 30, 2027
Est. primary completion date December 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria: - being a monolingual, native speaker of American English - absence of developmental, psychological, neurological, or communication disorders (other than developmental stuttering) as confirmed by a certified research SLP - normal (age-appropriate) binaural pure-tone hearing threshold (0.5-4k Hz; =25 dB HL for younger than 70 years, and =35 dB HL for older than 70 years) - not taking any medications that affect the central nervous system - absence of safety contra-indication for tDCS, TMS and MRI (for adults) - scoring at the 20th percentile or higher on standardized speech-language tests (for children) Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Delaying speech initiation
This intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use transcranial magnetic stimulation to induce a temporal misalignment between prediction and auditory feedback while participants produce speech.
Auditory errors and pre-speech auditory modulation
This intervention will examine the contributions of auditory errors to pre-speech auditory modulation. Participants will receive auditory perturbations while speaking, and we will collect their brain activities throughout the study.
Contributions of the speech premotor cortex to pre-speech auditory modulation
This intervention will examine the effects of stimulation of the left ventral premotor cortex on pre-speech auditory modulation. Participants will receive electrical stimulation while speaking.
Delaying auditory feedback
This intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use delayed auditory feedback to induce a temporal misalignment between prediction and auditory feedback while participants produce speech.

Locations

Country Name City State
United States Univeristy of Washington Seattle Washington
United States Arizona State University Tempe Arizona

Sponsors (3)

Lead Sponsor Collaborator
Arizona State University National Institute on Deafness and Other Communication Disorders (NIDCD), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in brain activity before and during speaking Participants will hear speech sounds in each trial before speaking or reading words. Participants' brain activity will be recorded while completing the speaking or reading tasks. The investigators will measure how the participant's brain activity in response to the played sounds changes during speaking and reading tasks. For this purpose, the investigators will measure the amplitude of the brain activity (in microvolts; µV) measured using a commercial electroencephalography system. The amplitude (µV) of the brain signals will be examined both before speaking and during speaking at two time points. within each session of the study that may last up to 2 hours
Primary change in speech when participants experience auditory errors In each trial, participants will experience an auditory error while they produce speech (e.g., they may say "head" but hear "had"). The investigators will measure how the participants' speech changes due to auditory errors that they experience in the current trial. For this p[purpose, the investigators will use commercial microphones to record speech signals and then examine the amplitude of the speech in specific frequency ranges (measured in Hertz; Hz). The frequencies (Hz) of speech in trials with auditory errors will be compared with those without auditory errors. within each session of the study that may last up to 2 hours
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