Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.

Stammering Clinical Trial

Official title:

Modifying Unconscious Tongue Movements to Improve Fluency in Adults With a Confirmed Developmental Stammer. A Pilot Randomised Feasibility Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310436
• Other study ID #: ITSligo HMcD
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: September 2, 2021

Study information

• Verified date: April 2020
• Source: Institute of Technology, Sligo
• Contact: Kenneth Monaghan, PhD
• Phone: 00353879480448
• Email: monaghan.kenneth[@]itsligo.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stammering
• Stuttering
• Unconsciousness

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Ireland	Institute of Technology, Sligo	Sligo	Co Sligo

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Technology, Sligo	Irish Research Council

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes.
Secondary	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.	10 minutes.
Secondary	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.	10 minutes.