Dopamine and Sensorimotor Function in Stuttering
ConditionStuttering, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Francisco
About this trial
This study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency. This study aims to understand sensorimotor pathways of stuttering and possible interventions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
native speakers of American English
for adults who stutter, presence of stuttering will be confirmed, with onset before age 6 years
Normal hearing
Ages of 18 to 65 years
Disqualifiers
self-reported speech-language-hearing difficulties other than stuttering
self-reported neurological or psychological problems
other medications (drugs that affect dopaminergic system and/or benzodiazepines)
Trial design
Design model
Crossover
Treatments tested in this trial
Aripiprazole 10 MG
DrugThe effects of aripiprazole on stuttering and various behavioral and neural outcomes will be studied compared to placebo.
Placebo
DrugPlacebo will be compared against aripiprazole for effect on stuttering and various behavioral and neural markers.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Single dose of aripiprazoleActive comparator 1 intervention
Group B: Placebo dosePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pre-speech auditory modulation
Pre-speech auditory modulation (PSAM) is a measure of auditory cortical activity (as collect via magnetoencephalography) in response to a speaking and and matching silent reading task.
Time frame
3-4 hours after intervention dose is delivered2
Speaking Induced Suppression (SIS)
SIS is a phenomenon measured through magnetoencephalography that is a marker of auditory cortical response to self-produced speech compared with playback of the same speech.
Time frame
3-4 hours after intervention3
Centering
This is a speech behavior associated with SIS involving a reduction of speech variability from speech onset to mid-utterances. This is derived from auditory recordings occurring during magnetoencephalography collection.
Time frame
3-4 hours after intervention4
Feedback alterations
This is a measure of fluency enhancement by altered speech feedback (manipulated by methods such as masking noise, frequency shifted feedback,. etc.) This is measured through audio recordings and brain activation patterns during magnetoencephalography.
Time frame
3-4 hours after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov