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

NCT04285099 | Unknown

• 1 other identifier: H-1902-132-1091
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Freezing of Gait, Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Stimulation frequency ratio in 4 weeks

  Proportion of two frequencies in 4 weeks

  4 weeks

Secondary Outcomes (5)

• Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week

  4 weeks

• Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week

  4 weeks

• Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week

  4 weeks

• Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week

  4 weeks

• Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week

  4 weeks

Study Arms (2)

PD patients with FOG after STN-DBS[A]

EXPERIMENTAL

Initially started by A setting

Device: Application of dual system in frequency A

PD patients with FOG after STN-DBS[B]

EXPERIMENTAL

Initially started by B setting

Device: Application of dual system in frequency B

Interventions

Application of dual system in frequency A 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[A]

Application of dual system in frequency B 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]

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Beom S Jeon

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Because our study is a double-blinded trial within one group, participant and investigator do not know whether the frequency is 130Hz or 60Hz.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)