- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06740968
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Improving Neural Oscillation and Synchrony Between Motor and Auditory Regions in Stuttering Using Personalized Transcranial Alternating Current Stimulation (tACS)
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Soo-Eun Chang, PhD
- Phone Number: 734-232-0300
- Email: sooeunc@umich.edu
Study Contact Backup
- Name: Emily Garnett, PhD
- Phone Number: 734-232-3371
- Email: emilyog@med.umich.edu
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Soo-Eun Chang, PhD
- Phone Number: 734-232-0300
- Email: sooeunc@umich.edu
-
Principal Investigator:
- Soo-Eun Chang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for stutterers:
- 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 for stutterers:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of stuttered syllables produced during speech sample
Time Frame: Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
The study will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample.
Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).
|
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change in perturbation response
Time Frame: Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
The study will compare the perturbation task from before and after tACS.
This is measured by the percent change in perturbation response.
|
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
|
Change in Phase Amplitude Coupling
Time Frame: Baseline (before 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.
Phase Amplitude Coupling (PAC) will be calculated within and between the two regions targeted by stimulation calculated as [pre(active-sham)] - [post(active-sham)] at each tACS visit.
|
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soo-Eun Chang, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stuttering
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- HUM00211167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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