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| ID | Type | Description | Link |
|---|---|---|---|
| R21DC021557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| University of Washington | OTHER |
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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.
Stuttering is a disorder of speech fluency that affects 3.5 million people in the USA alone. The goal of this project is to assess whether fluency ehnancement with auditory feedback manipulations or with pharmacological agents that regulate dopamine uptake improve the sensorimotor functions of speech feedback prediction and processing in stuttering.
This study may lay the foundation for stuttering treatments that combine dopamine regulators and behavioral treatments. Aripiprazole is an FDA-approved anti-psychotic typically used for treatment of schizophrenia or acute manic episodes. A typical dose is 10-15 mg per day, given daily for treatment. In this study, one 10 mg dose will be given. The usage in this study is purely investigational (experimental) and not FDA approved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of aripiprazole | Active Comparator | Single dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded. |
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| Placebo dose | Placebo Comparator | A single placebo dose will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole 10 MG | Drug | The effects of aripiprazole on stuttering and various behavioral and neural outcomes will be studied compared to placebo. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-4 hours after intervention dose is delivered |
| 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. | 3-4 hours after intervention |
| 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. | 3-4 hours after intervention |
| 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. | 3-4 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Brunwin, MS | Contact | 4154766888 | snl-bil@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Houde, PhD | University of California, San Francisco | Principal Investigator |
| Srikantan Nagarajan, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomagentic Imaging Lab | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32390816 | Background | Toyomura A, Miyashiro D, Kuriki S, Sowman PF. Speech-Induced Suppression for Delayed Auditory Feedback in Adults Who Do and Do Not Stutter. Front Hum Neurosci. 2020 Apr 24;14:150. doi: 10.3389/fnhum.2020.00150. eCollection 2020. | |
| 21095231 | Background | Beal DS, Quraan MA, Cheyne DO, Taylor MJ, Gracco VL, De Nil LF. Speech-induced suppression of evoked auditory fields in children who stutter. Neuroimage. 2011 Feb 14;54(4):2994-3003. doi: 10.1016/j.neuroimage.2010.11.026. Epub 2010 Nov 21. |
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Audio and video recordings to verify presence of stuttering will be shared with investigators at University of Washington. De-identified MEG data or results may also be shared with University of Washingotn.
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Placebo | Drug | Placebo will be compared against aripiprazole for effect on stuttering and various behavioral and neural markers. |
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| Ludo Max, PhD |
| University of Washington |
| Principal Investigator |
| 20452437 | Background | Beal DS, Cheyne DO, Gracco VL, Quraan MA, Taylor MJ, De Nil LF. Auditory evoked fields to vocalization during passive listening and active generation in adults who stutter. Neuroimage. 2010 Oct 1;52(4):1645-53. doi: 10.1016/j.neuroimage.2010.04.277. Epub 2010 May 7. |
| 29169049 | Background | Daliri A, Max L. Stuttering adults' lack of pre-speech auditory modulation normalizes when speaking with delayed auditory feedback. Cortex. 2018 Feb;99:55-68. doi: 10.1016/j.cortex.2017.10.019. Epub 2017 Nov 13. |
| 25796060 | Background | Daliri A, Max L. Modulation of auditory processing during speech movement planning is limited in adults who stutter. Brain Lang. 2015 Apr;143:59-68. doi: 10.1016/j.bandl.2015.03.002. Epub 2015 Mar 18. |
| 26335995 | Background | Daliri A, Max L. Electrophysiological evidence for a general auditory prediction deficit in adults who stutter. Brain Lang. 2015 Nov;150:37-44. doi: 10.1016/j.bandl.2015.08.008. Epub 2015 Aug 31. |
| 22241281 | Background | Park CH, Park TW, Yang JC, Lee KH, Huang GB, Tong Z, Park MS, Chung YC. No negative symptoms in healthy volunteers after single doses of amisulpride, aripiprazole, and haloperidol: a double-blind placebo-controlled trial. Int Clin Psychopharmacol. 2012 Mar;27(2):114-20. doi: 10.1097/YIC.0b013e3283502773. |
| 18626285 | Background | Tran NL, Maguire GA, Franklin DL, Riley GD. Case report of aripiprazole for persistent developmental stuttering. J Clin Psychopharmacol. 2008 Aug;28(4):470-2. doi: 10.1097/JCP.0b013e31817ea9ad. No abstract available. |
| 36112116 | Background | Kim BU, Kim HW, Park EJ, Kim JH, Boon-Yasidhi V, Tarugsa J, Reyes A, Manalo SG, Joung YS. Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study. J Child Adolesc Psychopharmacol. 2022 Sep;32(7):390-399. doi: 10.1089/cap.2022.0004. |
| 32292321 | Background | Maguire GA, Nguyen DL, Simonson KC, Kurz TL. The Pharmacologic Treatment of Stuttering and Its Neuropharmacologic Basis. Front Neurosci. 2020 Mar 27;14:158. doi: 10.3389/fnins.2020.00158. eCollection 2020. |
| 34924974 | Background | Alm PA. The Dopamine System and Automatization of Movement Sequences: A Review With Relevance for Speech and Stuttering. Front Hum Neurosci. 2021 Dec 2;15:661880. doi: 10.3389/fnhum.2021.661880. eCollection 2021. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |