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Non-invasive Brain Stimulation in Adults Who Stutter

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ClinicalTrials.gov Identifier: NCT03437512
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Emily O'Dell Garnett, University of Michigan

Brief Summary:
Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.

Condition or disease Intervention/treatment Phase
Stuttering, Developmental Device: Anodal tDCS Behavioral: Fluency training Device: Sham tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A researcher who is not involved in any aspect of the study will randomize participants into the sham and active study arms using a minimization procedure. Allocation concealment will be achieved by assigning a unique 6-digit random code per participant, which will be provided to the researcher. The code is used to deliver stimulation. The participants and the researchers who deliver stimulation, assess outcomes, and analyze data will be masked to trial arm.
Primary Purpose: Treatment
Official Title: Non-invasive Brain Stimulation in Adults Who Stutter
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arm Intervention/treatment
Experimental: Active tDCS and fluency training
Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).
Device: Anodal tDCS
20 minutes of 2mA anodal stimulation.

Behavioral: Fluency training
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes

Sham Comparator: Sham tDCS and fluency training
Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).
Behavioral: Fluency training
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes

Device: Sham tDCS
For sham stimulation, current is ramped up and back down over 30 seconds.




Primary Outcome Measures :
  1. Changes in brain activation as assessed by fMRI images [ Time Frame: Baseline, 1 week, 4 weeks ]
    Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by % Blood-Oxygen-Level-Dependent (BOLD) signal change.

  2. Change in percentage of stuttered syllables produced during speech sample [ Time Frame: Baseline, 1 week, 4 weeks ]
    Investigators 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).


Secondary Outcome Measures :
  1. Changes from baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES) [ Time Frame: Baseline, 1 week, 4 weeks ]
    The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 most negative impact). These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. The change on the total impact score will be used.


Other Outcome Measures:
  1. Changes from baseline on rhythm judgement task [ Time Frame: Baseline, 1 week, 4 weeks ]
    Investigators will compare performance accuracy on a computerized rhythm judgement task from before and after tDCS to assess effects of tDCS. Improved accuracy reflects better performance.

  2. Changes from baseline on tapping tasks [ Time Frame: Baseline, 1 week, 4 weeks ]
    Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.

  3. Changes from baseline on self-rated measure of speech fluency [ Time Frame: Baseline, 1 week, 4 weeks ]
    Investigators will compare participant scores on a self-rated measure of speech fluency (1 = NO STUTTERING; 9 = EXTREMELY SEVERE STUTTERING) from before and after tDCS to assess effects of tDCS. Lower scores indicate improvement.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of persistent developmental stuttering
  • stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
  • scores within 1 standard deviation of the norm on the standardized tests for the study

Exclusion Criteria:

  • received any treatment for stuttering within the past year
  • other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
  • taking any medications/drugs that affect brain function
  • history of past or current mental illness for example, schizophrenia that may affect brain development and function
  • history of serious medical or neurological illness such as epilepsy and Parkinson's disease
  • history of closed head injury (e.g., concussion)
  • history of reading disorders
  • hearing loss
  • taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study
  • metal or electronic implants such as cochlear implants, and pacemakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437512


Contacts
Contact: Emily O Garnett, PhD 734-232-3371 emilyog@med.umich.edu
Contact: Soo-Eun Chang, PhD 734-232-0300 sooeunc@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Emily O Garnett, PhD    734-232-3371    emilyog@med.umich.edu   
Sub-Investigator: Soo-Eun Chang, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Emily O Garnett, PhD University of Michigan

Responsible Party: Emily O'Dell Garnett, Postdoctoral Research Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT03437512     History of Changes
Other Study ID Numbers: HUM00134495
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Emily O'Dell Garnett, University of Michigan:
tDCS
MRI
Speech
fluency

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms