Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.

Institute of Technology, Sligo

Status: Suspended

Conditions: Stammering

Treatments: Behavioral: Modifying saccades by looking in air.; Behavioral: Modifying saccades by looking down to naval.

Study type: Interventional

Funder types: Other

Identifiers

NCT04310436

ITSligo HMcD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Looking down to naval.

Experimental group

Description:

Modifying Saccade origin by looking down to naval.

Treatment:

Behavioral: Modifying saccades by looking down to naval.

Looking up in the air.

Placebo Comparator group

Description:

Modifying Saccade origin by looking up in the air.

Treatment:

Behavioral: Modifying saccades by looking in air.