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

Seoul National University Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Application of dual system in frequency ADEVICE

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.

Application of dual system in frequency BDEVICE

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.

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Beom S Jeon

Seoul, South Korea

Outcomes

Primary Outcomes

Stimulation frequency ratio in 4 weeks

Proportion of two frequencies in 4 weeks

Time frame: 4 weeks

Secondary Outcomes

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. \[minimum 0, maximum 52\]

Time frame: 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. \[minimum 0, maximum 52\]

Time frame: 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. \[minimum 0, maximum 24\]

Time frame: 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. \[minimum 0, maximum 24\]

Time frame: 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. \[minimum 0, maximum 156\]

Data from ClinicalTrials.gov

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