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Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
behavioral intervention based on sensory cues
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Parkinson's disease who are aged 30 years or older
  • Patients who underwent bilateral subthalamic nucleus deep brain stimulation
  • Patients who complain of freezing of gait

Exclusion Criteria:

  • Patients who have already used sensory cues for freezing of gait in clinical practice
  • Patients with MMSE scores of 18 or lower
  • Patients with Hoehn-Yahr scale 5
  • Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PD with FOG

    Arm Description

    Patients with Parkinson's disease who complain of freezing of gait

    Outcomes

    Primary Outcome Measures

    Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Change from baseline to 4-week f/u in the number of falling
    We will ask about the average number of falling over the last week at baseline and at 4-week f/u.

    Secondary Outcome Measures

    Change from baseline to 4-week f/u in FOG-Q total score
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Change from baseline to 2-week f/u in FOG-Q
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Change from baseline to 2-week f/u in the number of falling
    We will ask about the average number of falling over the last week at baseline and at 2-week f/u.
    Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.

    Full Information

    First Posted
    October 30, 2019
    Last Updated
    December 16, 2019
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04147377
    Brief Title
    Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS
    Official Title
    Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.
    Detailed Description
    Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients. Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice. Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD with FOG
    Arm Type
    Experimental
    Arm Description
    Patients with Parkinson's disease who complain of freezing of gait
    Intervention Type
    Behavioral
    Intervention Name(s)
    behavioral intervention based on sensory cues
    Intervention Description
    Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.
    Primary Outcome Measure Information:
    Title
    Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
    Description
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Time Frame
    baseline, after 4 weeks
    Title
    Change from baseline to 4-week f/u in the number of falling
    Description
    We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
    Time Frame
    baseline, after 4 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline to 4-week f/u in FOG-Q total score
    Description
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Time Frame
    baseline, after 4 weeks
    Title
    Change from baseline to 2-week f/u in FOG-Q
    Description
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Time Frame
    baseline, after 2 weeks
    Title
    Change from baseline to 2-week f/u in the number of falling
    Description
    We will ask about the average number of falling over the last week at baseline and at 2-week f/u.
    Time Frame
    baseline, after 2 weeks
    Title
    Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
    Description
    The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
    Time Frame
    baseline, after 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Parkinson's disease who are aged 30 years or older Patients who underwent bilateral subthalamic nucleus deep brain stimulation Patients who complain of freezing of gait Exclusion Criteria: Patients who have already used sensory cues for freezing of gait in clinical practice Patients with MMSE scores of 18 or lower Patients with Hoehn-Yahr scale 5 Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Beomseok Jeon, Professor
    Phone
    +82-2-2072-2876
    Email
    brain@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beomseok Jeon, Professor
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS

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