Parkinson Disease
Conditions
Keywords
Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
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.
Interventions
DEVICEApplication of dual system in frequency A
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.
DEVICEApplication of dual system in frequency B
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation frequency ratio in 4 weeks | 4 weeks | Proportion of two frequencies in 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | Parkinson's Disease Questionnaire-39 score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. \[minimum 0, maximum 156\] |
Countries
South Korea
Outcome results
None listed