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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: behavioral intervention based on sensory cues


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD with FOG<br>Patients with Parkinson's disease who complain of freezing of gait | Behavioral: behavioral intervention based on sensory cues<br>* Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, after 4 weeks | 
| 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. | baseline, after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, after 4 weeks | 
| 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. | baseline, after 2 weeks | 
| 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. | baseline, after 2 weeks | 
| 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. | baseline, after 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation