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

March 18, 2017 updated by: Beijing Pins Medical Co., Ltd

Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100040
        • Tsinghua University Yuquan Hospital
      • Beijing, Beijing, China, 100050
        • Beijing Tian Tan Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VFS
variable frequency deep brain stimulation (VFS)
Device: Deep Brain Stimulation
Deep Brain Stimulation
ACTIVE_COMPARATOR: HFS
high frequency deep brain stimulation (HFS)
Device: Deep Brain Stimulation
Deep Brain Stimulation
ACTIVE_COMPARATOR: LFS
low frequency deep brain stimulation (LFS)
Device: Deep Brain Stimulation
Deep Brain Stimulation
NO_INTERVENTION: DBS off
deep brain stimulation off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) task
Time Frame: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
The outcome of TUG task at 12 months follow-up.
the number of freezing episodes for TUG task
Time Frame: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
The outcome of TUG task at 12 months follow-up.

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS III scores
Time Frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Outcome of VFS at 6、12 months with reference to baseline HFS
Gait and Falls Questionnaire (GFQ) scores
Time Frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Outcome of VFS at 6、12 months with reference to baseline HFS
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time Frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Outcome of VFS at 6、12 months with reference to baseline HFS
the Freezing of Gait Questionnaire (FOG-Q) scores
Time Frame: Outcome of VFS at 6 、12months with reference to baseline HFS
Outcome of VFS at 6 、12months with reference to baseline HFS
Number of adverse events (AE's)
Time Frame: Change from Baseline to 6、12 Months
Change from Baseline to 6、12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Investigators

  • Study Chair: Luming Li, Ph.D, Tsinghua University
  • Study Chair: Michael Okun, MD., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

November 8, 2015

First Posted (ESTIMATE)

November 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 18, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Deep Brain Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe