Frequency Effect of STN-DBS Through the Dual System on FOG in PD

Study Overview
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Brief Summary
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We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.

Detailed Description
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The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.

Official Title
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Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Application of dual system in frequency A
* Device: Application of dual system in frequency B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with PD who are aged 30 years or older patients with bilateral STN-DBS patients who have a FOG at their med off state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1 Exclusion Criteria: patients without FOG patients who have undergone DBS patients who have had previous brain surgery patients who have undergone reoperation of DBS patients who underwent unilateral DBS patients with cognitive impairment (MMSE <18)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD patients with FOG after STN-DBS[A]<br>Initially started by A setting | Device: Application of dual system in frequency A<br>* The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.<br>|
| Experimental: PD patients with FOG after STN-DBS[B]<br>Initially started by B setting | Device: Application of dual system in frequency B<br>* The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulation frequency ratio in 4 weeks | Proportion of two frequencies in 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 52] | 4 weeks | 
| Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 52] | 4 weeks | 
| Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 24] | 4 weeks | 
| Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week | Freezing of Gait Questionnaire score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 24] | 4 weeks | 
| Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week | Parkinson's Disease Questionnaire-39 score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 156] | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Freezing of Gait, Deep Brain Stimulation