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Recruiting NCT07215884

Dopamine and Sensorimotor Function in Stuttering

Phase I Interventional Stuttering, Adult

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: Aripiprazole 10 MG, Placebo.
Who it may be relevant to
Registry conditions: Stuttering, Adult. 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Drug Aripiprazole 10 MG
    The effects of aripiprazole on stuttering and various behavioral and neural outcomes will be studied compared to placebo.
  • Drug Placebo
    Placebo will be compared against aripiprazole for effect on stuttering and various behavioral and neural markers.

Primary outcome measures

  • Pre-speech auditory modulation [Time frame: 3-4 hours after intervention dose is delivered]
  • Speaking Induced Suppression (SIS) [Time frame: 3-4 hours after intervention]
  • Centering [Time frame: 3-4 hours after intervention]
  • Feedback alterations [Time frame: 3-4 hours after intervention]

Eligibility criteria

Inclusion criteria

  • 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
  • healthy adults without hearing-language difficulties

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Biomagentic Imaging Lab — San Francisco

Publications

  • 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. PMID 32390816
  • 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. PMID 21095231
  • 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. PMID 20452437
  • 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. PMID 29169049
  • 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. PMID 25796060
  • 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. PMID 26335995
  • 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. PMID 22241281
  • 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. PMID 18626285

Identifiers

NCT: NCT07215884 · 1R21DC021557-01A1 · R21DC021557

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗