Transcranial Alternating Current Stimulation (tACS) in Stuttering
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
transcranial alternating current stimulation (tACS)
DeviceDuring 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).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: transcranial alternating current stimulation (tACS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Phase Synchronization
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.
Time frame
Baseline (pre-tACS), approximately 3 hours (post-tACS) (visits 3-5)Secondary outcomes
1
Percentage of stuttered syllables produced during speech sample
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).
Time frame
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)Other outcomes
1
Percent change in perturbation response
The study will compare the perturbation task from before and after tACS. This is measured by the percent change in perturbation response.
Time frame
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)2
Change in Phase Amplitude Coupling
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.
Time frame
Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5)Sponsors and contacts
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Source ClinicalTrials.gov