Transcranial Alternating Current Stimulation (tACS) in Stuttering
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial alternating current stimulation (tACS).
- Who it may be relevant to
- Registry conditions: Stuttering, Adult, Stuttering, Childhood, Stuttering, Developmental. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Neural Oscillation and Synchrony Between Motor and Auditory Regions in Stuttering Using Personalized Transcranial Alternating Current Stimulation (tACS)
Overview
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.
Interventions
- Device 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).
Primary outcome measures
- Change in Phase Synchronization [Time frame: Baseline (pre-tACS), approximately 3 hours (post-tACS) (visits 3-5)]
Secondary outcome measures (1)
- Percentage of stuttered syllables produced during speech sample [Time frame: Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06740968 · HUM00211167