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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-02-28

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.

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Because our study is a double-blinded trial within one group, participant and investigator do not know whether the frequency is 130Hz or 60Hz.

Study Groups

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PD patients with FOG after STN-DBS[A]

Initially started by A setting

Group Type EXPERIMENTAL

Application of dual system in frequency A

Intervention Type DEVICE

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.

PD patients with FOG after STN-DBS[B]

Initially started by B setting

Group Type EXPERIMENTAL

Application of dual system in frequency B

Intervention Type DEVICE

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.

Interventions

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Application 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.

Intervention Type DEVICE

Application 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.

Intervention Type DEVICE

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)

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes