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Completed

NCT Number: NCT02288598

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

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.

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Key information

Conditions

Stuttering Communication Disorders Fluency Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford

Oxford, OX1 3UD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anodal tDCS

Device

20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge.

Fluency Training

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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