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

NCT ID: NCT02288598

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stuttering Fluency Disorders Speech Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Anodal TDCS

Intervention Type DEVICE

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

Fluency Training

Intervention Type BEHAVIORAL

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

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).

Group Type SHAM_COMPARATOR

Fluency Training

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anodal TDCS

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

Intervention Type DEVICE

Fluency Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kate Watkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Oxford

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.psy.ox.ac.uk/research/speech-brain-research-group

Speech and Brain Research Group, University of Oxford

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSD-IDREC-C2-2014-013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Speech Signals in Stuttering
NCT05668923 RECRUITING NA
Speech Processing in Stuttering
NCT04929184 COMPLETED NA
Spacing Lidcombe Program Clinic Visits
NCT00680303 UNKNOWN PHASE2