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

Seoul National University

Status: Unknown

Conditions: Parkinson Disease

Treatments: Device: Application of dual system in frequency B; Device: Application of dual system in frequency A

Study type: Interventional

Funder types: Other

Identifiers

NCT04285099

H-1902-132-1091

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups

PD patients with FOG after STN-DBS[A]

Experimental group

Description:

Initially started by A setting

Treatment:

Device: Application of dual system in frequency A

PD patients with FOG after STN-DBS[B]

Experimental group

Description:

Initially started by B setting

Treatment:

Device: Application of dual system in frequency B