ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 337 for:    "Speech Disorders"

Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02288598
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This study aims to test whether the addition of transcranial direct current stimulation (TDCS) to speech fluency training results in improvements in speech fluency in adults with developmental stuttering. Half of the participants will receive anodal TDCS on five consecutive days, the other half will receive a sham stimulation for the same amount of time.

Condition or disease Intervention/treatment Phase
Stuttering Fluency Disorders Speech Disorders Device: Anodal TDCS Behavioral: Fluency Training Not Applicable

Detailed Description:
Studies using TDCS have shown improvements in motor performance, and in expressive language skills in clinical and healthy populations. The benefits of single sessions of TDCS are short-lived. However, stimulation over multiple sessions can increase and prolong learning effects that can persist for several weeks after the end of the stimulation period. We aim to target left hemisphere frontal regions involved in speech production with TDCS, and to pair this stimulation with speech fluency training.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
Study Start Date : October 2014
Actual Primary Completion Date : March 14, 2016
Actual Study Completion Date : March 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arm Intervention/treatment
Experimental: Anodal TDCS
Participants will receive anodal TDCS over the left inferior frontal cortex. TDCS will be delivered at 1milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).
Device: Anodal TDCS
20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge.

Behavioral: Fluency Training
Speech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech.

Sham Comparator: Sham TDCS
Participants will receive sham TDCS over the left inferior frontal cortex. Sham stimulation will involve 30 seconds stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).
Behavioral: Fluency Training
Speech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech.




Primary Outcome Measures :
  1. Change from baseline proportion of stuttering in speech sample [ Time Frame: 1 week post-treatment ]
    Quantitative measurement of stuttering

  2. Change from baseline proportion of stuttering in speech sample [ Time Frame: 6 weeks post-treatment ]
    Quantitative measurement of stuttering


Secondary Outcome Measures :
  1. Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4) [ Time Frame: 1 week post-treatment ]
    Standardised assessment of frequency and duration of stuttering and associated physical concomitants

  2. Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4) [ Time Frame: 6 weeks post-treatment ]
    Standardised assessment of frequency and duration of stuttering and associated physical concomitants

  3. Change from baseline on Overall Assessment of Speaker's Experience of Stuttering (OASES) [ Time Frame: 6 weeks post-treatment ]
    Standardised assessment of the functional impact of stuttering on a person's life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Native speaker of English.
  • Right handed.
  • Participant has moderate to severe Developmental Stuttering (Stammering)

Exclusion Criteria:

  • Speech, language or communication disorder other than Developmental Stuttering.
  • Sensory impairment (hearing loss or visual impairment)
  • History of drug abuse.
  • History of seizures
  • History of a neurological or psychiatric illness.
  • History of neurosurgical procedure.
  • Currently taking certain prescription medications such as anti-depressants and anti-malarial medication (as these may lower the seizure threshold)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288598


Locations
United Kingdom
University of Oxford
Oxford, United Kingdom, OX1 3UD
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Kate Watkins, PhD University of Oxford

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02288598     History of Changes
Other Study ID Numbers: MSD-IDREC-C2-2014-013
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by University of Oxford:
Stammering
Brain stimulation

Additional relevant MeSH terms:
Disease
Stuttering
Speech Disorders
Pathologic Processes
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms