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Stimulation of the Thalamus to Ameliorate Persistent Disfluency (SToPeD)

Primary Purpose

Persistent Developmental Stutter, Childhood-Onset Fluency Disorder (Stuttering)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
System On
System off
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Developmental Stutter focused on measuring Deep Brain Stimulation

Eligibility Criteria

19 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults between the ages of 19 and 76 years old Individuals with persistent developmental stutter refractory to intensive speech therapy, as diagnosed by a speech and language therapist. Exclusion Criteria: Children and adolescents will not be included, as there is a significant percentage of developmental stuttering that will spontaneously resolve in this age group. Patients who have not trialed standard therapy will not be included in this study. Patients with mild symptoms. Patients who have a neurodegenerative disease. Patients with a bleeding diathesis. Patients who are unable to communicate. MRI Specific Exclusion criteria: Patients with a cardiac pacemaker or defibrillator. Patient with an insulin or infusion pump. Patients with a cochlear, otologic, or ear implant. Patients with an implant held in place by a magnet. Patients with tissue expanders. Patients with implanted clips, catheters, clamps, valves, or other metal. Patients with tattoos or permanent makeup above shoulders. Patients with shrapnel or other retained metal. Patients who are pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Deep Brain Simulation (DBS) System

    Arm Description

    The DBS device will be turned on to compare stutter to when the device was off (which would be the control).

    Outcomes

    Primary Outcome Measures

    Change of One-Page Suttering Assessment from Baseline to Post-Operation
    Objectively assesses individual's stutter. Divide the number of instances of stuttering by the number of syllables in the sample and multiply by 100 to obtain the percentage of stuttered syllables.

    Secondary Outcome Measures

    Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation
    A 10-question, 5 point rating scale assessment, with higher scores reflecting a worse subjective voice-related quality of life.
    Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation
    5-point scale that indicates the amount of adverse impact a person experiences due to stuttering, with higher scores indicating higher levels of negative impact.

    Full Information

    First Posted
    November 23, 2022
    Last Updated
    October 10, 2023
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05641701
    Brief Title
    Stimulation of the Thalamus to Ameliorate Persistent Disfluency
    Acronym
    SToPeD
    Official Title
    Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 15, 2024 (Anticipated)
    Study Completion Date
    November 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Persistent developmental stutter / childhood onset fluency disorder is a disabling condition leading to significant communication and psychological disability. Established treatment consists of intensive speech therapy, and whilst initially effective, has a waning long-term benefit. Our research team aims to provide evidence of stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation. The investigators propose to perform bilateral DBS on 3 participants with stutter refractory to intensive speech therapy, to determine a response in their stutter. The assessments will be double-blinded. The investigators will use the outcome of this small pilot study to determine the feasibility and details of a larger randomized controlled trial.
    Detailed Description
    Suitable participants are referred by speech pathology centers, after having failed an intensive speech therapy program. Referred participants are contacted by the Neurosurgery DBS Clinic, and assessed for suitability and willingness to participate. These potential participants will be contacted by the DBS Clinic at Vancouver General Hospital to discuss the scope of the study, and educate them about deep brain stimulation. Those who wish to be included in the study will attend a face-to-face appointment at the DBS Clinic. At the initial appointment, informed consent will take place. Baseline assessments will be undertaken, including the Overall Assessment of the Speaker's Experience of Stuttering (OASES), Voice-related Quality of Life (VRQoL), and "The One Page Stuttering Assessment". The participants will be referred for a functional MRI for mapping of speech and language laterality. The participants will then undergo surgery for implantation of a bilateral thalamic DBS system. They will stay overnight in the hospital, and have a post-operative CT scan on the first post-operative day. This scan will be used to assess accuracy of electrode placement, as per usual technique. 4 weeks post-operatively, the participants will attend the DBS Clinic for programming of their devices. 4 weeks after device programming, the participants will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on, bilateral electrodes off, left electrode on, and right electrode on, as well as OASES and VRQoL. The scores from the 1-page stutter assessment, as well as pre- and post-operative OASES and VRQoL, will be compared via the Wilcoxan rank sum test for nonparametric repeated measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Developmental Stutter, Childhood-Onset Fluency Disorder (Stuttering)
    Keywords
    Deep Brain Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    3 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep Brain Simulation (DBS) System
    Arm Type
    Experimental
    Arm Description
    The DBS device will be turned on to compare stutter to when the device was off (which would be the control).
    Intervention Type
    Device
    Intervention Name(s)
    System On
    Intervention Description
    The DBS system will be turned on, and the individual's stutter will be assessed.
    Intervention Type
    Device
    Intervention Name(s)
    System off
    Intervention Description
    The DBS system will be turned off, and the individual's stutter will be assessed.
    Primary Outcome Measure Information:
    Title
    Change of One-Page Suttering Assessment from Baseline to Post-Operation
    Description
    Objectively assesses individual's stutter. Divide the number of instances of stuttering by the number of syllables in the sample and multiply by 100 to obtain the percentage of stuttered syllables.
    Time Frame
    Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on.
    Secondary Outcome Measure Information:
    Title
    Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation
    Description
    A 10-question, 5 point rating scale assessment, with higher scores reflecting a worse subjective voice-related quality of life.
    Time Frame
    Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses quality of life post surgery.
    Title
    Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation
    Description
    5-point scale that indicates the amount of adverse impact a person experiences due to stuttering, with higher scores indicating higher levels of negative impact.
    Time Frame
    Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses subjective voice experience post surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults between the ages of 19 and 76 years old Individuals with persistent developmental stutter refractory to intensive speech therapy, as diagnosed by a speech and language therapist. Exclusion Criteria: Children and adolescents will not be included, as there is a significant percentage of developmental stuttering that will spontaneously resolve in this age group. Patients who have not trialed standard therapy will not be included in this study. Patients with mild symptoms. Patients who have a neurodegenerative disease. Patients with a bleeding diathesis. Patients who are unable to communicate. MRI Specific Exclusion criteria: Patients with a cardiac pacemaker or defibrillator. Patient with an insulin or infusion pump. Patients with a cochlear, otologic, or ear implant. Patients with an implant held in place by a magnet. Patients with tissue expanders. Patients with implanted clips, catheters, clamps, valves, or other metal. Patients with tattoos or permanent makeup above shoulders. Patients with shrapnel or other retained metal. Patients who are pregnant.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Danielle Pietramala
    Phone
    604-875-4111
    Ext
    68396
    Email
    danielle.pietram@ubc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher R Honey

    12. IPD Sharing Statement

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    Stimulation of the Thalamus to Ameliorate Persistent Disfluency

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