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Non-invasive Brain Stimulation in Adults Who Stutter

Primary Purpose

Stuttering, Developmental

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anodal tDCS
Fluency training
Sham tDCS
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering, Developmental focused on measuring transcranial direct current stimulation, MRI, Speech, fluency, tDCS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS and fluency training

Sham tDCS and fluency training

Arm Description

Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).

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).

Outcomes

Primary Outcome Measures

Changes in Brain Activation as Assessed by fMRI Images
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.
Change in Percentage of Stuttered Syllables Produced During Speech Sample
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

Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)
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.

Full Information

First Posted
February 12, 2018
Last Updated
April 28, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03437512
Brief Title
Non-invasive Brain Stimulation in Adults Who Stutter
Official Title
Non-invasive Brain Stimulation in Adults Who Stutter
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 paused human subjects research at study site, funding expired.
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Developmental
Keywords
transcranial direct current stimulation, MRI, Speech, fluency, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS and fluency training
Arm Type
Experimental
Arm Description
Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).
Arm Title
Sham tDCS and fluency training
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
20 minutes of 2mA anodal stimulation.
Intervention Type
Behavioral
Intervention Name(s)
Fluency training
Intervention Description
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
For sham stimulation, current is ramped up and back down over 30 seconds.
Primary Outcome Measure Information:
Title
Changes in Brain Activation as Assessed by fMRI Images
Description
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.
Time Frame
Baseline, 1 week (post), 4 weeks (follow up)
Title
Change in Percentage of Stuttered Syllables Produced During Speech Sample
Description
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).
Time Frame
Baseline, 1 week (post), 4 weeks (follow up)
Secondary Outcome Measure Information:
Title
Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)
Description
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.
Time Frame
Baseline, 1 week (post), 4 weeks (follow up)
Other Pre-specified Outcome Measures:
Title
Changes From Baseline on Rhythm Judgement Task
Description
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.
Time Frame
Baseline, 1 week, 4 weeks
Title
Changes From Baseline on Tapping Tasks
Description
Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.
Time Frame
Baseline, 1 week, 4 weeks
Title
Changes From Baseline on Self-rated Measure of Speech Fluency
Description
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.
Time Frame
Baseline, 1 week, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily O Garnett, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

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Non-invasive Brain Stimulation in Adults Who Stutter

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