Non-invasive Brain Stimulation in Adults Who Stutter

NCT03437512 | Terminated Results FDA Device

• 1 other identifier: HUM00134495
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stuttering, Developmental

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

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

  Baseline, 1 week (post), 4 weeks (follow up)

Other Outcomes (3)

• Changes From Baseline on Rhythm Judgement Task

  Baseline, 1 week, 4 weeks

• Changes From Baseline on Tapping Tasks

  Baseline, 1 week, 4 weeks

• Changes From Baseline on Self-rated Measure of Speech Fluency

  Baseline, 1 week, 4 weeks

Study Arms (2)

Active tDCS and fluency training

EXPERIMENTAL

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

Device: Anodal tDCS; Behavioral: Fluency training

Sham tDCS and fluency training

SHAM COMPARATOR

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; Device: Sham tDCS

Interventions

Anodal tDCS DEVICE

20 minutes of 2mA anodal stimulation.

Active tDCS and fluency training

Fluency training BEHAVIORAL

Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes

Active tDCS and fluency training; Sham tDCS and fluency training

Sham tDCS DEVICE

For sham stimulation, current is ramped up and back down over 30 seconds.

Sham tDCS and fluency training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Stuttering; Speech

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Study was terminated early due to pandemic research pause, which resulted in fewer enrolled subjects than anticipated, which affected the number of subjects that could be analyzed.

Results Point of Contact

• Title: Emily O. Garnett, PhD, CCC-SLP
• Organization: University of Michigan

emilyog@med.umich.edu

734-232-3371

Study Officials

• Emily O Garnett, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: June 25, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

US (1)