Non-invasive Brain Stimulation in Adults Who Stutter

NCT ID: NCT03437512

Last Updated: 2021-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stuttering, Developmental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Active tDCS and fluency training

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

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

20 minutes of 2mA anodal stimulation.

Fluency training

Intervention Type BEHAVIORAL

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

Sham tDCS and fluency training

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).

Group Type SHAM_COMPARATOR

Fluency training

Intervention Type BEHAVIORAL

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

Sham tDCS

Intervention Type DEVICE

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

Interventions

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Anodal tDCS

20 minutes of 2mA anodal stimulation.

Intervention Type DEVICE

Fluency training

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

Intervention Type BEHAVIORAL

Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Emily O'Dell Garnett

Research Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily O Garnett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUM00134495

Identifier Type: -

Identifier Source: org_study_id

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