Clinical trial NCT04310436: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Stammering
Keywords: Neuroplasticity
Eye saccades
Unconscious tongue movement
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2020-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomised Placebo Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stammering Severity (SSI-4) (Howell et. al. 2011).
timeFrame: 10 minutes.
Secondary outcomes:
measure: Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).
timeFrame: 10 minutes.
measure: Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).
timeFrame: 10 minutes.
Other outcomes:
Locations:
city: Sligo
country: Ireland
facility: Institute of Technology, Sligo
state: Co Sligo
Study officials:
affiliation: Study Principal Investigator
name: Hilary Mc Donagh, MSc
role: PRINCIPAL_INVESTIGATOR
References: