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Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring DBS, VFS, FOG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients were receiving bilateral STN stimulation for more than six months.
  2. They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
  3. Subjects had an ability to walk at least 10 meters independently during ON DBS condition.

Exclusion criteria:

  1. gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
  2. any change in the HFS DBS settings, three months prior to participation in the study.
  3. complete inability to walk despite assistance while DBS ON.
  4. Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
  5. Subjects could not tolerate prolonged OFF medication condition.

Sites / Locations

  • Tsinghua University Yuquan Hospital
  • Beijing Tian Tan Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

VFS

HFS

LFS

DBS off

Arm Description

variable frequency deep brain stimulation (VFS)

high frequency deep brain stimulation (HFS)

low frequency deep brain stimulation (LFS)

deep brain stimulation off

Outcomes

Primary Outcome Measures

Timed Up and Go (TUG) task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
the number of freezing episodes for TUG task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)

Secondary Outcome Measures

UPDRS III scores
Gait and Falls Questionnaire (GFQ) scores
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
the Freezing of Gait Questionnaire (FOG-Q) scores
Number of adverse events (AE's)

Full Information

First Posted
October 12, 2015
Last Updated
March 18, 2017
Sponsor
Beijing Pins Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02601144
Brief Title
Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease
Official Title
Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).
Detailed Description
HFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of them experienced loss of efficacy in the short term. Then comes to the little improvement or even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied. The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS and LFS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
DBS, VFS, FOG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VFS
Arm Type
Experimental
Arm Description
variable frequency deep brain stimulation (VFS)
Arm Title
HFS
Arm Type
Active Comparator
Arm Description
high frequency deep brain stimulation (HFS)
Arm Title
LFS
Arm Type
Active Comparator
Arm Description
low frequency deep brain stimulation (LFS)
Arm Title
DBS off
Arm Type
No Intervention
Arm Description
deep brain stimulation off
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG) task
Description
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Time Frame
The outcome of TUG task at 12 months follow-up.
Title
the number of freezing episodes for TUG task
Description
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Time Frame
The outcome of TUG task at 12 months follow-up.
Secondary Outcome Measure Information:
Title
UPDRS III scores
Time Frame
Outcome of VFS at 6、12 months with reference to baseline HFS
Title
Gait and Falls Questionnaire (GFQ) scores
Time Frame
Outcome of VFS at 6、12 months with reference to baseline HFS
Title
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time Frame
Outcome of VFS at 6、12 months with reference to baseline HFS
Title
the Freezing of Gait Questionnaire (FOG-Q) scores
Time Frame
Outcome of VFS at 6 、12months with reference to baseline HFS
Title
Number of adverse events (AE's)
Time Frame
Change from Baseline to 6、12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were receiving bilateral STN stimulation for more than six months. They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait. Subjects had an ability to walk at least 10 meters independently during ON DBS condition. Exclusion criteria: gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease. any change in the HFS DBS settings, three months prior to participation in the study. complete inability to walk despite assistance while DBS ON. Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing). Subjects could not tolerate prolonged OFF medication condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luming Li, Ph.D
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Okun, MD.
Organizational Affiliation
University of Florida
Official's Role
Study Chair
Facility Information:
Facility Name
Tsinghua University Yuquan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100040
Country
China
Facility Name
Beijing Tian Tan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

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Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease

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