Non-invasive Brain Stimulation in Adults Who Stutter

• ClinicalTrials.gov Identifier: NCT03437512
• Recruitment Status: Terminated
• First Posted: February 19, 2018
• Results First Posted: April 29, 2021
• Last Update Posted: April 29, 2021
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Emily O'Dell Garnett, University of Michigan

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 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
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Changes in Brain Activation as Assessed by fMRI Images [ Time Frame: Baseline, 1 week (post), 4 weeks (follow up) ]
   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 (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for [post-pre] and [follow up-pre] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.
2. Change in Percentage of Stuttered Syllables Produced During Speech Sample [ Time Frame: Baseline, 1 week (post), 4 weeks (follow up) ]
   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 (post), 4 weeks (follow up) ]
   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. Changes are shown in the table below by comparison between the measurements at the three points in time.

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Emily O Garnett, PhD; University of Michigan

  Study Documents (Full-Text)

Documents provided by Emily O'Dell Garnett, University of Michigan:

Study Protocol and Statistical Analysis Plan  [PDF] February 25, 2021

More Information

• Responsible Party: Emily O'Dell Garnett, Research Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT03437512
• Other Study ID Numbers: HUM00134495
• First Posted: February 19, 2018
• Results First Posted: April 29, 2021
• Last Update Posted: April 29, 2021
• Last Verified: April 2021

• 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:

transcranial direct current stimulation; MRI; Speech; fluency; tDCS

Additional relevant MeSH terms:

Stuttering; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases