StutteringNCT02288598
Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
A study testing Anodal TDCS and Fluency Training in people with Stuttering and Fluency Disorders, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Stuttering, Fluency Disorders, Speech Disorders
- What is being tested?
- Anodal TDCS and Fluency Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to 14 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Native speaker of English.
- Right handed.
- Participant has moderate to severe Developmental Stuttering (Stammering)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stuttering, Fluency Disorders, Speech Disorders
- Being tested
- Anodal TDCS, Fluency Training
- Keywords
- Stammering, Brain stimulation
- Medical subject headings
- Stuttering, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal TDCSDevice
20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge.
Fluency TrainingBehavioural
Speech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Anodal TDCS; Behavioral: 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). Receives: Behavioral: Fluency Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline proportion of stuttering in speech sample
Quantitative measurement of stuttering
Measured: 1 week post-treatment
Change from baseline proportion of stuttering in speech sample
Quantitative measurement of stuttering
Measured: 6 weeks post-treatment
Secondary outcomes (3)
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Measured: 1 week post-treatment
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Standardised assessment of frequency and duration of stuttering and associated physical concomitants
Measured: 6 weeks post-treatment
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
Measured: 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion14 Mar 2016
- Study completion14 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Watkins, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288598
- Sponsor's protocol ID
- MSD-IDREC-C2-2014-013
- Status last verified
- Jan 2017
- First submitted
- 30 Sep 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
- ClinicalTrials.gov ID
- NCT02288598
- Acronym / sponsor ID
- MSD-IDREC-C2-2014-013
- Conditions
- Stuttering, Fluency Disorders, Speech Disorders
- Keywords
- Stammering, Brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 14 Mar 2016 (actual)
- Study completion
- 14 Mar 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal TDCS | Experimental | Device: Anodal TDCS, Behavioral: Fluency TrainingParticipants 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). |
| Sham TDCS | Sham comparator | Behavioral: Fluency TrainingParticipants 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Native speaker of English.
- Right handed.
- Participant has moderate to severe Developmental Stuttering (Stammering)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal TDCS20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge. | Device | Anodal TDCS |
| Fluency TrainingSpeech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech. | Behavioural | Anodal TDCS, Sham TDCS |
Primary outcome
Change from baseline proportion of stuttering in speech sample
Time frame: 1 week post-treatment
Quantitative measurement of stuttering
Change from baseline proportion of stuttering in speech sample
Time frame: 6 weeks post-treatment
Quantitative measurement of stuttering
3 secondary outcomes
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Time frame: 1 week post-treatment
Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4)
Time frame: 6 weeks post-treatment
Change from baseline on Overall Assessment of Speaker's Experience of Stuttering (OASES)
Time frame: 6 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Speech and Brain Research Group, University of OxfordLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Watkins, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal TDCS and Fluency Training in people with Stuttering and Fluency Disorders, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline proportion of stuttering in speech sample (time frame: 1 week post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.