StammeringNCT04310436
Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.
A study testing Modifying saccades by looking down to naval. and Modifying saccades by looking in air. in people with Stammering, run by Institute of Technology, Sligo at 1 site in Ireland.
Trial summary
This is a pilot randomised controlled trial investigating whether using modification of saccadic eye movements can control lateral unconscious tongue positioning and enhance fluency in adults with a confirmed developmental stammer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stammering
- What is being tested?
- Modifying saccades by looking down to naval. and Modifying saccades by looking in air.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 10 Mar 2020to 2 Sep 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age > 18 years.
- A diagnosis of confirmed developmental stammer from SALT characterized by stammering on ≥ 3% of syllables.
- A proficiency in the English Language.
- No diagnosis of any emotional, behavioural, learning or neurological disorder.
- Cognitive ability to take part.
- Have previously completed a course of outpatient treatment for confirmed developmental stammer.
Who cannot join
- Younger than 18 years.
- Not having completed a traditional intervention for stammer.
- This research is not intended to replace current interventions but provide additional possibilities for those adults who have completed a standard programme of intervention and their developmental stammer still persists and a rate of ≥ 3% of syllables
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifying Unconscious Tongue Movements to Improve Fluency in Adults With a Confirmed Developmental Stammer. A Pilot Randomised Feasibility Study.
This is a pilot randomised controlled trial investigating whether using modification of saccadic eye movements can control lateral unconscious tongue positioning and enhance fluency in adults with a confirmed developmental stammer. This study is being conducted as part of an MSc by research qualification at the Institute of Technology Sligo in Ireland with a view to extending to PhD. The setting is home setting with all assessments either taking place at home via video link or in the institute. The study is being conducted in conjunction with the Community Speech and Language Therapist and has attained ethical approval through Sligo University Hospital (SUH) Ethics Committee.
Read the detailed description
Participants will be assessed for stammering severity either on line via video link or in the Institute of Technology Sligo Health Science \& Exercise Physiology Lab (B2004) at three time points: before intervention, after a five-week trial period and three months post completion. Participants will complete two assessments at each time to cater for "off" days. Participants will be required to practice quick eye movements at the start of words / syllables where dysfluencies are predicted for 10 minutes twice a day for the treatment period. Training in eye movement (saccade) modification will occur following the initial assessment in IT Sligo, or video link.
Participants will be assigned to one of two treatment arms. An experimental arm, and a control (placebo) arm. All participants will be assessed regarding their premonitory awareness of anticipated dysfluencies both before training and at the three month Based on advice from Community Speech and language Manager (Ms Sinead Carthy), participants will voice/video message the principle investigator once per week for this five-week period to confirm compliance.
- Conditions
- Stammering
- Being tested
- Modifying saccades by looking down to naval., Modifying saccades by looking in air.
- Keywords
- Neuroplasticity, Eye saccades, Unconscious tongue movement
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modifying saccades by looking down to naval.Behavioural
Paragraphs from list Provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly down to their naval to reset the lateral tongue position.
Modifying saccades by looking in air.Behavioural
Paragraphs from list provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly up to reset the lateral tongue position.
| Study group | Role | What they receive |
|---|---|---|
| Looking down to naval. | Experimental | Modifying Saccade origin by looking down to naval. Receives: Behavioral: Modifying saccades by looking down to naval. |
| Looking up in the air. | Placebo comparator | Modifying Saccade origin by looking up in the air. Receives: Behavioral: Modifying saccades by looking in air. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stammering Severity (SSI-4) (Howell et. al. 2011).
Measures stuttering severity in adults and children. It measures the percentage of stuttered syllables versus fluent speech in the participant. It also measures the frequency of repetition and prolongations, duration of blocks, and physical concomitants.
Measured: 10 minutes.
Secondary outcomes (2)
Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).
Measures the impact of stuttering on a person's life. Scores range between 1 (Mild) and 5 (Severe). The impact is broken down to four sections: General Information, Speaker's reactions, Daily Communication and Quality of life. There is also an overall impact score.
Measured: 10 minutes.
Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).
Measures the anticipation effect in stuttering. 14 items assessing premonitory awareness of stuttering sensation to assess the individual's capacity, manner and style of anticipation. Each item consists of a 4-point Likert scale ranging from "not at all" to "very much". A higher score indicates a larger anticipation of stuttering by the participant.
Measured: 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start10 Mar 2020
- Primary completion10 Dec 2026 (estimated)
- Study completion2 Sep 2027 (estimated)
Why it stopped: Researcher needing time off
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StammeringStudies of the same condition, open and under way.
- 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
- Pilot Randomised Placebo Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Technology, Sligo
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Research Council
- Responsible party
- Sponsor
- Investigators
- Hilary Mc Donagh, MSc, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310436
- Sponsor's protocol ID
- ITSligo HMcD
- Status last verified
- Oct 2024
- First submitted
- 13 Mar 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Unconscious Tongue Movements to Improve Fluency in Adults With a Confirmed Developmental Stammer. A Pilot Randomised Feasibility Study.
- ClinicalTrials.gov ID
- NCT04310436
- Acronym / sponsor ID
- ITSligo HMcD
- Conditions
- Stammering
- Keywords
- Neuroplasticity, Eye saccades, Unconscious tongue movement
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Researcher needing time off
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Technology, SligoUniversity, hospital or other
- Collaborators
- Irish Research Council
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 17 Mar 2020 (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 is a pilot randomised controlled trial investigating whether using modification of saccadic eye movements can control lateral unconscious tongue positioning and enhance fluency in adults with a confirmed developmental stammer. This study is being conducted as part of an MSc by research qualification at the Institute of Technology Sligo in Ireland with a view to extending to PhD. The setting is home setting with all assessments either taking place at home via video link or in the institute. The study is being conducted in conjunction with the Community Speech and Language Therapist and has attained ethical approval through Sligo University Hospital (SUH) Ethics Committee.
Detailed description
Participants will be assessed for stammering severity either on line via video link or in the Institute of Technology Sligo Health Science \& Exercise Physiology Lab (B2004) at three time points: before intervention, after a five-week trial period and three months post completion. Participants will complete two assessments at each time to cater for "off" days. Participants will be required to practice quick eye movements at the start of words / syllables where dysfluencies are predicted for 10 minutes twice a day for the treatment period. Training in eye movement (saccade) modification will occur following the initial assessment in IT Sligo, or video link.
Participants will be assigned to one of two treatment arms. An experimental arm, and a control (placebo) arm. All participants will be assessed regarding their premonitory awareness of anticipated dysfluencies both before training and at the three month Based on advice from Community Speech and language Manager (Ms Sinead Carthy), participants will voice/video message the principle investigator once per week for this five-week period to confirm compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Looking down to naval. | Experimental | Behavioral: Modifying saccades by looking down to naval.Modifying Saccade origin by looking down to naval. |
| Looking up in the air. | Placebo comparator | Behavioral: Modifying saccades by looking in air.Modifying Saccade origin by looking up in the air. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age > 18 years.
- A diagnosis of confirmed developmental stammer from SALT characterized by stammering on ≥ 3% of syllables.
- A proficiency in the English Language.
- No diagnosis of any emotional, behavioural, learning or neurological disorder.
- Cognitive ability to take part.
Key exclusion criteria (3 listed)
- Younger than 18 years.
- Not having completed a traditional intervention for stammer.
- This research is not intended to replace current interventions but provide additional possibilities for those adults who have completed a standard programme of intervention and their developmental stammer still persists and a rate of ≥ 3% of syllables
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 |
|---|---|---|
| Modifying saccades by looking down to naval.Paragraphs from list Provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly down to their naval to reset the lateral tongue position. | Behavioural | Looking down to naval. |
| Modifying saccades by looking in air.Paragraphs from list provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly up to reset the lateral tongue position. | Behavioural | Looking up in the air. |
Primary outcome
Stammering Severity (SSI-4) (Howell et. al. 2011).
Time frame: 10 minutes.
Measures stuttering severity in adults and children. It measures the percentage of stuttered syllables versus fluent speech in the participant. It also measures the frequency of repetition and prolongations, duration of blocks, and physical concomitants.
2 secondary outcomes
Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).
Time frame: 10 minutes.
Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).
Time frame: 10 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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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.
Hilary Mc Donagh, MSc principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modifying saccades by looking down to naval. and Modifying saccades by looking in air. in people with Stammering, run by Institute of Technology, Sligo at 1 site in Ireland.
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 6 inclusion and 3 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: paused, as of the sponsor's last update on 26 Oct 2024. 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 Ireland. 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?
Results are not available in the source record.
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?
Stammering Severity (SSI-4) (Howell et. al. 2011). (time frame: 10 minutes.). 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 26 Oct 2024.