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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Application of dual system in frequency A; Device: Application of dual system in frequency B

• Registration Number: NCT04285099
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Last Update Submitted: 2020-02-24
• Study First Posted: 2020-02-26
• Last Update Posted: 2020-02-26
• Study Start: 2020-03-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD patients with FOG after STN-DBS[A]	Application of dual system in frequency A	Initially started by A setting
PD patients with FOG after STN-DBS[B]	Application of dual system in frequency B	Initially started by B setting

Primary Outcome Measures

Name	Time	Method
Stimulation frequency ratio in 4 weeks	4 weeks	Proportion of two frequencies in 4 weeks

Secondary Outcome Measures

Name	Time	Method
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 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 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. \[minimum 0, maximum 156\]

Trial Locations

Locations (1)

Beom S Jeon; 🇰🇷 Seoul, Korea, Republic of