Modifying Unconscious Tongue Movements in Adults With Developmental Stammer.

NCT04310436 | Suspended

• 1 other identifier: ITSligo HMcD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stammering

Keywords

Neuroplasticity; Eye saccades; Unconscious tongue movement

Outcome Measures

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.

  10 minutes.

Secondary Outcomes (2)

• Stammering Experience Overall Assessment of the Speaker's Experience of Stuttering OASES-A (Yaruss & Quesal 2006).

  10 minutes.

• Premonitory Awareness in Stuttering Scale (PAiS) (Cholin et. al. 2016).

  10 minutes.

Study Arms (2)

Looking down to naval.

EXPERIMENTAL

Modifying Saccade origin by looking down to naval.

Behavioral: Modifying saccades by looking down to naval.

Looking up in the air.

PLACEBO COMPARATOR

Modifying Saccade origin by looking up in the air.

Behavioral: Modifying saccades by looking in air.

Interventions

Modifying saccades by looking down to naval. BEHAVIORAL

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.

Looking down to naval.

Modifying saccades by looking in air. BEHAVIORAL

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.

Looking up in the air.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Technology, Sligo: lead
• Irish Research Council: collaborator

Study Sites (1)

Institute of Technology, Sligo

Sligo, Co Sligo, F91YW50, Ireland

Location

MeSH Terms

Conditions

Stuttering

Interventions

Air

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Hilary Mc Donagh, MSc

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomised Placebo Controlled Trial

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: March 10, 2020
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): September 2, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IE (1)