Frequency Effect of STN-DBS Through the Dual System on FOG in PD
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Application of dual system in frequency A
Application of dual system in frequency B
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
Eligibility Criteria
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)
Sites / Locations
- Beom S Jeon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PD patients with FOG after STN-DBS[A]
PD patients with FOG after STN-DBS[B]
Arm Description
Initially started by A setting
Initially started by B setting
Outcomes
Primary Outcome Measures
Stimulation frequency ratio in 4 weeks
Proportion of two frequencies in 4 weeks
Secondary Outcome Measures
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]
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]
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]
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]
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]
Full Information
NCT ID
NCT04285099
First Posted
February 24, 2020
Last Updated
February 24, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04285099
Brief Title
Frequency Effect of STN-DBS Through the Dual System on FOG in PD
Official Title
Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Masking Description
Because our study is a double-blinded trial within one group, participant and investigator do not know whether the frequency is 130Hz or 60Hz.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD patients with FOG after STN-DBS[A]
Arm Type
Experimental
Arm Description
Initially started by A setting
Arm Title
PD patients with FOG after STN-DBS[B]
Arm Type
Experimental
Arm Description
Initially started by B setting
Intervention Type
Device
Intervention Name(s)
Application of dual system in frequency A
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Application of dual system in frequency B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stimulation frequency ratio in 4 weeks
Description
Proportion of two frequencies in 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week
Description
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]
Time Frame
4 weeks
Title
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week
Description
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]
Time Frame
4 weeks
Title
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week
Description
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]
Time Frame
4 weeks
Title
Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week
Description
Freezing of Gait Questionnaire score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Time Frame
4 weeks
Title
Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week
Description
Parkinson's Disease Questionnaire-39 score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 156]
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Beom S Jeon
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Frequency Effect of STN-DBS Through the Dual System on FOG in PD
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