Non-invasive Brain Stimulation in Adults Who Stutter

Stuttering, Developmental Clinical Trial

Official title:

Non-invasive Brain Stimulation in Adults Who Stutter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03437512
• Other study ID #: HUM00134495
• Status: Terminated
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stuttering
• Stuttering, Developmental

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes From Baseline on Rhythm Judgement Task	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.	Baseline, 1 week, 4 weeks
Other	Changes From Baseline on Tapping Tasks	Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.	Baseline, 1 week, 4 weeks
Other	Changes From Baseline on Self-rated Measure of Speech Fluency	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.	Baseline, 1 week, 4 weeks
Primary	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.	Baseline, 1 week (post), 4 weeks (follow up)
Primary	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).	Baseline, 1 week (post), 4 weeks (follow up)
Secondary	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.	Baseline, 1 week (post), 4 weeks (follow up)