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

Parkinson Disease Clinical Trial

Official title:

Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04285099
• Other study ID #: H-1902-132-1091
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Beom S Jeon	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulation frequency ratio in 4 weeks	Proportion of two frequencies in 4 weeks	4 weeks
Secondary	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]	4 weeks
Secondary	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]	4 weeks
Secondary	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]	4 weeks
Secondary	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]	4 weeks
Secondary	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]	4 weeks