NCT02288598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

September 30, 2014

Last Update Submit

January 30, 2017

Conditions

StutteringFluency DisordersSpeech Disorders

Keywords

StammeringBrain stimulation

Outcome Measures

Primary Outcomes (2)

  • Change from baseline proportion of stuttering in speech sample

    Quantitative measurement of stuttering

    1 week post-treatment

  • Change from baseline proportion of stuttering in speech sample

    Quantitative measurement of stuttering

    6 weeks post-treatment

Secondary Outcomes (3)

  • Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)

    1 week post-treatment

  • Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)

    6 weeks post-treatment

  • Change from baseline on Overall Assessment of Speaker's Experience of Stuttering (OASES)

    6 weeks post-treatment

Study Arms (2)

Anodal TDCS

EXPERIMENTAL

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 TDCSBehavioral: Fluency Training

Sham TDCS

SHAM COMPARATOR

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

Interventions

Anodal TDCSDEVICE

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

Anodal TDCS
Fluency TrainingBEHAVIORAL

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

Anodal TDCSSham TDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, OX1 3UD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

StutteringSpeech Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Kate Watkins, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

November 11, 2014

Study Start

October 1, 2014

Primary Completion

March 14, 2016

Study Completion

March 14, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

GB(1)