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

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT02288598

Collaborator

(none)

Enrollment

Location

Arms

17.4

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stuttering Fluency Disorders Speech Disorders	Device: Anodal TDCS Behavioral: Fluency Training	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2014

Actual Primary Completion Date :

Mar 14, 2016

Actual Study Completion Date :

Mar 14, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline proportion of stuttering in speech sample [1 week post-treatment]
Quantitative measurement of stuttering
Change from baseline proportion of stuttering in speech sample [6 weeks post-treatment]
Quantitative measurement of stuttering

Secondary Outcome Measures

Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4) [1 week post-treatment]
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4) [6 weeks post-treatment]
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) [6 weeks post-treatment]
Standardised assessment of the functional impact of stuttering on a person's life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)