Non-invasive Brain Stimulation in Adults Who Stutter

University of Michigan

Status: Terminated

Conditions: Stuttering, Developmental

Treatments: Device: Sham tDCS; Behavioral: Fluency training; Device: Anodal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03437512

HUM00134495

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups

Active tDCS and fluency training

Experimental group

Description:

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

Treatment:

Device: Anodal tDCS

Behavioral: Fluency training

Sham tDCS and fluency training

Sham Comparator group

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).

Treatment:

Device: Sham tDCS

Behavioral: Fluency training