Non-invasive Brain Stimulation in Adults Who Stutter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Change in Percentage of Stuttered Syllables Produced During Speech Sample
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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).
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.
Secondary Outcomes
- Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)(Baseline, 1 week (post), 4 weeks (follow up))
Investigators
Emily O'Dell Garnett
Research Investigator
University of Michigan