Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
Primary Purpose
Stuttering, Fluency Disorders, Speech Disorders
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Anodal TDCS
Fluency Training
Sponsored by
About this trial
This is an interventional treatment trial for Stuttering focused on measuring Stammering, Brain stimulation
Eligibility 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)
Sites / Locations
- University of Oxford
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal TDCS
Sham TDCS
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Change from baseline proportion of stuttering in speech sample
Quantitative measurement of stuttering
Change from baseline proportion of stuttering in speech sample
Quantitative measurement of stuttering
Secondary Outcome Measures
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Change from baseline on Overall Assessment of Speaker's Experience of Stuttering (OASES)
Standardised assessment of the functional impact of stuttering on a person's life
Full Information
NCT ID
NCT02288598
First Posted
September 30, 2014
Last Updated
January 30, 2017
Sponsor
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT02288598
Brief Title
Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
Official Title
Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 14, 2016 (Actual)
Study Completion Date
March 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Fluency Disorders, Speech Disorders
Keywords
Stammering, Brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal TDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham TDCS
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Anodal TDCS
Intervention Description
20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge.
Intervention Type
Behavioral
Intervention Name(s)
Fluency Training
Intervention Description
Speech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech.
Primary Outcome Measure Information:
Title
Change from baseline proportion of stuttering in speech sample
Description
Quantitative measurement of stuttering
Time Frame
1 week post-treatment
Title
Change from baseline proportion of stuttering in speech sample
Description
Quantitative measurement of stuttering
Time Frame
6 weeks post-treatment
Secondary Outcome Measure Information:
Title
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Description
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Time Frame
1 week post-treatment
Title
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Description
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Time Frame
6 weeks post-treatment
Title
Change from baseline on Overall Assessment of Speaker's Experience of Stuttering (OASES)
Description
Standardised assessment of the functional impact of stuttering on a person's life
Time Frame
6 weeks post-treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Watkins, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX1 3UD
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.psy.ox.ac.uk/research/speech-brain-research-group
Description
Speech and Brain Research Group, University of Oxford
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Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
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