Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.
Primary Purpose
Stammering
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Modifying saccades by looking down to naval.
Modifying saccades by looking in air.
Sponsored by
About this trial
This is an interventional treatment trial for Stammering focused on measuring Neuroplasticity, Eye saccades, Unconscious tongue movement
Eligibility Criteria
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:
- 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
Sites / Locations
- Institute of Technology, SligoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Looking down to naval.
Looking up in the air.
Arm Description
Modifying Saccade origin by looking down to naval.
Modifying Saccade origin by looking up in the air.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04310436
First Posted
March 13, 2020
Last Updated
April 17, 2020
Sponsor
Institute of Technology, Sligo
Collaborators
Irish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT04310436
Brief Title
Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.
Official Title
Modifying Unconscious Tongue Movements to Improve Fluency in Adults With a Confirmed Developmental Stammer. A Pilot Randomised Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Anticipated)
Study Completion Date
September 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Technology, Sligo
Collaborators
Irish Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stammering
Keywords
Neuroplasticity, Eye saccades, Unconscious tongue movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomised Placebo Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
Experimental Group instructed to modify saccadic origin by looking to naval for the start of the words dysfluencies were predicted
Placebo Group instructed to modify saccadic origin by looking up for the start of the words dysfluencies were predicted
Outcome assessor was blinded to treatment allocation. Participants Stammering behaviour to be assessed using SSI-4 a reliable validated objective measure of stuttering severity. Participants stammering behaviour is to be recorded via video link or in a separate lab and the assessor will be asked asked not to discuss the technique prescribed given to patients. Even if the patient mentioned the trials they would not discuss the intervention
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Looking down to naval.
Arm Type
Experimental
Arm Description
Modifying Saccade origin by looking down to naval.
Arm Title
Looking up in the air.
Arm Type
Placebo Comparator
Arm Description
Modifying Saccade origin by looking up in the air.
Intervention Type
Behavioral
Intervention Name(s)
Modifying saccades by looking down to naval.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modifying saccades by looking in air.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stammering Severity (SSI-4) (Howell et. al. 2011).
Description
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 Outcome Measure Information:
Title
Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).
Description
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.
Title
Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Monaghan, PhD
Phone
00353879480448
Email
monaghan.kenneth@itsligo.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Hilary Mc Donagh, MSc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary Mc Donagh, MSc
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Technology, Sligo
City
Sligo
State/Province
Co Sligo
ZIP/Postal Code
F91YW50
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Monaghan, PhD
Phone
00353719155222
Email
monaghan.kenneth@itsligo.ie
First Name & Middle Initial & Last Name & Degree
John Bartlett, PhD
Phone
00353719155222
Email
bartlett.john@itsligo.ie
12. IPD Sharing Statement
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Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.
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