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

Speech Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288598
• Other study ID #: MSD-IDREC-C2-2014-013
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: January 30, 2017
• Start date: October 2014
• Est. completion date: March 14, 2016

Study information

• Verified date: January 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 14, 2016
• Est. primary completion date: March 14, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Fluency Disorders
• Speech Disorders
• Stuttering

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline proportion of stuttering in speech sample	Quantitative measurement of stuttering	1 week post-treatment
Primary	Change from baseline proportion of stuttering in speech sample	Quantitative measurement of stuttering	6 weeks post-treatment
Secondary	Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)	Standardised assessment of frequency and duration of stuttering and associated physical concomitants	1 week post-treatment
Secondary	Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)	Standardised assessment of frequency and duration of stuttering and associated physical concomitants	6 weeks post-treatment
Secondary	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	6 weeks post-treatment

External Links

•   Speech and Brain Research Group, University of Oxford