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SuspendedNCT04310436Updated Oct 26, 2024

Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.

An interventional study of Modifying saccades by looking down to naval. and Modifying saccades by looking in air. in Stammering, sponsored by Institute of Technology, Sligo. Suspended at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Institute of Technology, Sligo · Not applicable, Interventional, and Treatment

Why this study was suspended
Researcher needing time off
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Stammering

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Keywords

  • Neuroplasticity
  • Eye saccades
  • Unconscious tongue movement
03

In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 60 is above the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

Institute of Technology, Sligo is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Looking down to naval.

    Modifying Saccade origin by looking down to naval.

    Behavioral: Modifying saccades by looking down to naval.

  • Placebo comparator
    Looking up in the air.

    Modifying Saccade origin by looking up in the air.

    Behavioral: Modifying saccades by looking in air.

Interventions

  • BehavioralModifying 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.

  • BehavioralModifying 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes.

Secondary outcomes

  1. 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.

    Time frame: 10 minutes.

  2. 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.

    Time frame: 10 minutes.

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Study locations

1 site
  • Institute of Technology, Sligo
    Sligo, Co Sligo F91YW50, Ireland
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04310436
Lead sponsor
Institute of Technology, Sligo
Collaborators
Irish Research Council
Responsible party
Sponsor
First posted
Mar 17, 2020
Start date
Mar 10, 2020
Primary completion
Dec 10, 2026 (estimated)
Completion
Sep 2, 2027 (estimated)
Last update
Oct 26, 2024

Study contacts

Hilary Mc Donagh, MSc
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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