Stuttering, DevelopmentalINSTEPNCT03335722
Investigating Non-invasive Brain Stimulation to Enhance Fluency in People Who Stutter
A study testing Metronome-timed speech and Active tDCS in people with Stuttering, Developmental, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study aims to test whether the application of transcranial direct current stimulation (tDCS) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Developmental
- What is being tested?
- Metronome-timed speech and Active tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2017to 1 Jun 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Diagnosed with developmental stuttering of mild-moderate or greater severity
- Native speaker of English
- Normal or corrected-to-normal vision
- Normal hearing
Who cannot join
- Speech, language or communication disorder other than developmental stuttering.
- Contraindication to brain stimulation (tDCS or TMS)
- Contraindication to MRI
- History of drug abuse
- History of a neurological or psychiatric illness
- Any previous neurosurgical procedures
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- Taking prescription or over-the-counter medication that may affect brain function (for example, anti-depressants)
- Family history of epilepsy (first degree relative)
- Severe claustrophobia (as they may be unable to tolerate scanner)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Experimental Psychology, University of Oxford
Oxford, OX2 6BW
About this study
This study aims to test whether the application of transcranial direct current stimulation (tDCS) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention.
Read the detailed description
Developmental stuttering affects 5% of children and persists to adulthood in about 1%. Changing the way speech is produced in adults who stutter is a particular challenge for speech and language therapy and there is a need for novel interventions. One such intervention involves the application of transcranial direct current stimulation (tDCS) alongside therapies aimed at improving speech fluency. tDCS influences brain activity by modulating neuronal plasticity through the application of weak electrical currents across the brain. Pairing tDCS with speech therapy has potential for producing larger or longer lasting effects and reducing time spent in therapy.
The study will evaluate the potential of tDCS combined with speech fluency training to improve outcomes in people who stutter (PWS). PWS will have this training while receiving tDCS for five days (1 milliampere [mA] for 20 mins per day) in a double-blind randomized controlled trial. Outcomes will be measured in terms of changes to stuttering severity.
An additional research questions is how changes in interactions between sensory and motor brain regions relate to changes in speech fluency in PWS. MRI will be used to measure brain structure and function and the vocal tract during speech production. Transcranial magnetic stimulation (TMS) will assess motor excitability before and after the training.
- Conditions
- Stuttering, Developmental
- Being tested
- Metronome-timed speech, Active tDCS, Sham tDCS
- Keywords
- stammering, speech motor disorder, electrical current stimulation, metronome-timed speech
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronome-timed speechBehavioural
Reading, narrative, and conversational speech tasks will be completed on each of the five intervention days. Metronome- timed speech will be practiced during these tasks, at near-normal (comfortable) speech rate for each participant. Each intervention session will be 40 minutes in duration.
Active tDCSDevice
1-mA tDCS with the anode (5 x 7 cm) placed over the left frontal cortex and the cathode (5 x 7 cm) placed symmetrically over the right frontal cortex. tDCS will be delivered using a direct current (DC) stimulator in 'study-mode' for 20 minutes. The current is ramped up to 1 mA over the first 15 seconds of stimulation and maintained at this level for remainder of the 20-minute stimulation session.
Sham tDCSDevice
Sham stimulation will be delivered using a DC-stimulator in 'study-mode' for 20 minutes. Participants will receive sham stimulation with the anode and cathode electrodes placed over the left and right frontal cortex as in the active arm. For sham stimulation, the current is ramped up over 15 seconds, maintained for 15 seconds at 1 mA and ramped down over 15 seconds at the start of stimulation and is then followed by brief (3ms) pulses every 55 seconds for the remainder of the 20-minute stimulation session.
| Study group | Role | What they receive |
|---|---|---|
| Active TDCS and Fluency Intervention | Active comparator | Participants will receive 1-milliamp (mA) tDCS with the anode (5 x 7 cm) placed over the left frontal cortex and the cathode (5 x 7 cm) placed symmetrically over the right frontal cortex. tDCS will be delivered using a direct current (DC) stimulator in 'study-mode' for 20 minutes a day for five consecutive days. he stimulation will be applied for the first half of a 40-minute speech fluency training paradigm, using metronome-timed speech. Receives: Behavioral: Metronome-timed speech; Device: Active tDCS |
| Sham TDCS and Fluency Intervention | Sham comparator | Participants will receive sham stimulation with the anode and cathode electrodes placed over the left and right frontal cortex as in the active arm. Sham stimulation will be delivered using a DC-stimulator in 'study-mode' for 20 minutes a day for five consecutive days. For sham stimulation, the current is ramped up over 15 seconds, maintained for 15 seconds at 1 mA and ramped down over 15 seconds at the start of stimulation and is then followed by brief (3ms) pulses every 55 seconds for the remainder of the 20-minute stimulation session. he stimulation will be applied for the first half of a 40-minute speech fluency training paradigm, using metronome-timed speech. Receives: Behavioral: Metronome-timed speech; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stuttering Severity Instrument (SSI-4) Score
The Stuttering Severity Instrument (SSI-4) is a standardised measure of stuttering severity comprised of 3 sub-scores (frequency, duration and physical concomitants) which are summed to give a total score. We will use change from baseline in total score (i.e. baseline subtracted) on the Stuttering Severity Instrument version 4 measured post intervention. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. Therefore, larger negative change scores represent better outcomes (larger reductions in stuttering severity).
Measured: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
Secondary outcomes (3)
Change in percentage of disfluent syllables produced during conversation
Change from baseline (i.e. baseline subtracted) in percentage of disfluent syllables produced during a two-minute conversation sample. Larger negative change scores represent better outcomes (larger reductions in frequency of disfluency).
Measured: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
Change in percentage of disfluent syllables produced during reading
Change from baseline (i.e. baseline subtracted) in percentage of disfluent syllables produced during a two-minute reading sample. Larger negative change scores represent better outcomes (larger reductions in frequency of disfluency).
Measured: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
Change in Overall Assessment of the Speaker's Experience of Stuttering (OASES) score
The Overall Assessment of the Speaker's Experience of Stuttering (OASES) is a standardised self-assessment to measure the effect of stuttering on a person's life, comprising of 4 sub-scores (general information about speech, your reactions to stuttering, communication in daily situations, quality of life). The total score (out of a possible 500) is divided by the number of items (out of a possible 100. Note that some items may not apply to all participants). This gives a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life.
We will use change from baseline in total score (i.e. baseline subtracted) on the OASES total impact score, measured post intervention, as an outcome. Larger negative change scores represent better outcomes (larger reductions in negative impact of stuttering ).
Measured: 6 weeks and 12 weeks after the end of the 5-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start15 Nov 2017
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, DevelopmentalStudies 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
- Model description
- Double-blind, placebo-controlled (sham tDCS), randomised trial, with 20 participants with developmental stuttering recruited for each of the two arms of the trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate E Watkins, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335722
- Sponsor's protocol ID
- R52173/RE001_
- Acronym
- INSTEP
- Status last verified
- May 2022
- First submitted
- 26 Oct 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Non-invasive Brain Stimulation to Enhance Fluency in People Who Stutter
- ClinicalTrials.gov ID
- NCT03335722
- Acronym / sponsor ID
- INSTEP / R52173/RE001_
- Conditions
- Stuttering, Developmental
- Keywords
- stammering, speech motor disorder, electrical current stimulation, metronome-timed speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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 application of transcranial direct current stimulation (tDCS) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention.
Detailed description
Developmental stuttering affects 5% of children and persists to adulthood in about 1%. Changing the way speech is produced in adults who stutter is a particular challenge for speech and language therapy and there is a need for novel interventions. One such intervention involves the application of transcranial direct current stimulation (tDCS) alongside therapies aimed at improving speech fluency. tDCS influences brain activity by modulating neuronal plasticity through the application of weak electrical currents across the brain. Pairing tDCS with speech therapy has potential for producing larger or longer lasting effects and reducing time spent in therapy.
The study will evaluate the potential of tDCS combined with speech fluency training to improve outcomes in people who stutter (PWS). PWS will have this training while receiving tDCS for five days (1 milliampere [mA] for 20 mins per day) in a double-blind randomized controlled trial. Outcomes will be measured in terms of changes to stuttering severity.
An additional research questions is how changes in interactions between sensory and motor brain regions relate to changes in speech fluency in PWS. MRI will be used to measure brain structure and function and the vocal tract during speech production. Transcranial magnetic stimulation (TMS) will assess motor excitability before and after the 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
- Model description
- Double-blind, placebo-controlled (sham tDCS), randomised trial, with 20 participants with developmental stuttering recruited for each of the two arms of the trial.
| Arm | Type | Receives |
|---|---|---|
| Active TDCS and Fluency Intervention | Active comparator | Behavioral: Metronome-timed speech, Device: Active tDCSParticipants will receive 1-milliamp (mA) tDCS with the anode (5 x 7 cm) placed over the left frontal cortex and the cathode (5 x 7 cm) placed symmetrically over the right frontal cortex. tDCS will be delivered using a direct current (DC) stimulator in 'study-mode' for 20 minutes a day for five consecutive days. he stimulation will be applied for the first half of a 40-minute speech fluency training paradigm, using metronome-timed speech. |
| Sham TDCS and Fluency Intervention | Sham comparator | Behavioral: Metronome-timed speech, Device: Sham tDCSParticipants will receive sham stimulation with the anode and cathode electrodes placed over the left and right frontal cortex as in the active arm. Sham stimulation will be delivered using a DC-stimulator in 'study-mode' for 20 minutes a day for five consecutive days. For sham stimulation, the current is ramped up over 15 seconds, maintained for 15 seconds at 1 mA and ramped down over 15 seconds at the start of stimulation and is then followed by brief (3ms) pulses every 55 seconds for the remainder of the 20-minute stimulation session. he stimulation will be applied for the first half of a 40-minute speech fluency training paradigm, using metronome-timed speech. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Diagnosed with developmental stuttering of mild-moderate or greater severity
- Native speaker of English
- Normal or corrected-to-normal vision
- Normal hearing
Key exclusion criteria (9 listed)
- Speech, language or communication disorder other than developmental stuttering.
- Contraindication to brain stimulation (tDCS or TMS)
- Contraindication to MRI
- History of drug abuse
- 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 |
|---|---|---|
| Metronome-timed speechReading, narrative, and conversational speech tasks will be completed on each of the five intervention days. Metronome- timed speech will be practiced during these tasks, at near-normal (comfortable) speech rate for each participant. Each intervention session will be 40 minutes in duration. | Behavioural | Active TDCS and Fluency Intervention, Sham TDCS and Fluency Intervention |
| Active tDCS1-mA tDCS with the anode (5 x 7 cm) placed over the left frontal cortex and the cathode (5 x 7 cm) placed symmetrically over the right frontal cortex. tDCS will be delivered using a direct current (DC) stimulator in 'study-mode' for 20 minutes. The current is ramped up to 1 mA over the first 15 seconds of stimulation and maintained at this level for remainder of the 20-minute stimulation session. | Device | Active TDCS and Fluency Intervention |
| Sham tDCSSham stimulation will be delivered using a DC-stimulator in 'study-mode' for 20 minutes. Participants will receive sham stimulation with the anode and cathode electrodes placed over the left and right frontal cortex as in the active arm. For sham stimulation, the current is ramped up over 15 seconds, maintained for 15 seconds at 1 mA and ramped down over 15 seconds at the start of stimulation and is then followed by brief (3ms) pulses every 55 seconds for the remainder of the 20-minute stimulation session. | Device | Sham TDCS and Fluency Intervention |
Primary outcome
Change in Stuttering Severity Instrument (SSI-4) Score
Time frame: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
The Stuttering Severity Instrument (SSI-4) is a standardised measure of stuttering severity comprised of 3 sub-scores (frequency, duration and physical concomitants) which are summed to give a total score. We will use change from baseline in total score (i.e. baseline subtracted) on the Stuttering Severity Instrument version 4 measured post intervention. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. Therefore, larger negative change scores represent better outcomes (larger reductions in stuttering severity).
3 secondary outcomes
Change in percentage of disfluent syllables produced during conversation
Time frame: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
Change in percentage of disfluent syllables produced during reading
Time frame: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
Change in Overall Assessment of the Speaker's Experience of Stuttering (OASES) score
Time frame: 6 weeks and 12 weeks after the end of the 5-day intervention
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 18 May 2022.
- INSTEP trial websiteLink provided by the sponsor.
- Speech and Brain Research Group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 E 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 Metronome-timed speech and Active tDCS in people with Stuttering, Developmental, 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 5 inclusion and 9 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 18 May 2022. 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 in Stuttering Severity Instrument (SSI-4) Score (time frame: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention). 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 18 May 2022.