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Clinical Trials/NCT06740968
NCT06740968
Recruiting
N/A

Improving Neural Oscillation and Synchrony Between Motor and Auditory Regions in Stuttering Using Personalized Transcranial Alternating Current Stimulation (tACS)

University of Michigan1 site in 1 country80 target enrollmentAugust 5, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stuttering, Adult
Sponsor
University of Michigan
Enrollment
80
Locations
1
Primary Endpoint
Change in Phase Synchronization
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this study is to investigate how mild, noninvasive electrical brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people that stutter. The long-term goal of this study is to test the therapeutic potential of transcranial alternating current stimulation (tACS) for the treatment of stuttering.

The study team hypothesizes that if stuttering involves impaired initiation of motor programs, delta-tuned tACS will strengthen communication between brain regions and decrease stuttering. Therefore, delta-tuned sensorimotor tACS will be paired with fluency-induced speech (choral reading), which is hypothesized to decrease stuttering via improved auditory motor integration.

Detailed Description

Participants will have screening and baseline visits that include a variety of tests and procedures (i.e. standardized tests of speech, language, hearing test, music training questionnaire, working memory tests, and speech sample to characterize stuttering, magnetic resonance imaging (MRI) and electroencephalography (EEG)). Following these, participants will have 3 sessions (active and sham conditions) and then a one month follow-up phone or video call. Of note, there will be an embedded pilot study to refine the experimental protocol in terms of practicality and feasibility and these participants will not be included in this registration. The only purpose of this embedded study is to refine the protocol and it does not have any health or behavioral outcomes.

Registry
clinicaltrials.gov
Start Date
August 5, 2025
End Date
December 1, 2029
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Soo-Eun Chang

Associate Professor of Psychiatry

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Phase Synchronization

Time Frame: Baseline (pre-tACS), approximately 3 hours (post-tACS) (visits 3-5)

The study will compare EEG data recorded before and after stimulation to determine if tACS contributed to any changes. This will be measured by Phase Locking Value (PLV; measured from 0 to 1) between the two regions targeted by stimulation calculated as \[pre(active-sham)\] - \[post(active-sham)\] at each tACS visit.

Secondary Outcomes

  • Percentage of stuttered syllables produced during speech sample(Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5))

Study Sites (1)

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