Transcranial Alternating Current Stimulation (tACS) in Stuttering

NCT ID: NCT06740968

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Stuttering, Adult Stuttering, Childhood Stuttering, Developmental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants will all receive the same treatments, however, visits 3 through 5 will have order of conditions (types of stimulation) randomized.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Please note that because the most logical interventional study model is a single arm study the study team can't select a masking option. Please note that Participants, Investigators, and Outcomes Assessors will be blinded to active vs. sham stimulation (with the exception of one study investigator that pre-configures the randomization schedule, and this person will not be involved in any assessments/outcomes).

Study Groups

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transcranial alternating current stimulation (tACS)

Participants will receive 3 sessions of tACS. Each session can be active or sham. The stimulation parameters regarding the active and sham will not be disclosed at this time to maintain blind to participants. At the end of the trial the study will be updated to list these.

Group Type EXPERIMENTAL

transcranial alternating current stimulation (tACS)

Intervention Type DEVICE

During each of the 3 stimulation visits, participants will be seated in a comfortable position and a cap will be placed on participant's head similar to a swimming cap. Small electrodes will be placed near the surface of the scalp at certain regions of interest, and a weak electrical current will be passed through the electrodes into speech related brain areas for 20 minutes. The study team will not use current strengths exceeding 2 milliamps (mA).

Interventions

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transcranial alternating current stimulation (tACS)

During each of the 3 stimulation visits, participants will be seated in a comfortable position and a cap will be placed on participant's head similar to a swimming cap. Small electrodes will be placed near the surface of the scalp at certain regions of interest, and a weak electrical current will be passed through the electrodes into speech related brain areas for 20 minutes. The study team will not use current strengths exceeding 2 milliamps (mA).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have normal language, hearing, and cognition
* Speak English as the primary language
* Currently stutter
* Score (per protocol) a certain value on the Stuttering Severity Instrument (SSI-4).
* Have not received any treatment for stuttering within the past year

Exclusion Criteria

* History of seizures
* Major medical or neurological illness (e.g., stroke, serious head trauma, brain infection, Parkinson's disease, etc.)
* History of closed head injury with loss of consciousness (e.g., concussion)
* Metal or electronic implants such as cochlear implants and pacemakers anywhere in the body
* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
* Currently pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Soo-Eun Chang

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo-Eun Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Soo-Eun Chang, PhD

Role: CONTACT

734-232-0300

Emily Garnett, PhD

Role: CONTACT

734-232-3371

Facility Contacts

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Soo-Eun Chang, PhD

Role: primary

734-232-0300

Other Identifiers

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HUM00211167

Identifier Type: -

Identifier Source: org_study_id

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