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NCT Number: NCT02601144

Variable Frequency Stimulation of Subthalamic Nucleus 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tian Tan Hospital,Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep brain stimulation

Device

Deep Brain Stimulation

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. UPDRS III scores

    Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS

  2. Gait and Falls Questionnaire (GFQ) scores

    Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS

  3. the39-item Parkinson's Disease Questionnaire (PDQ-39) scores

    Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS

  4. the Freezing of Gait Questionnaire (FOG-Q) scores

    Time frame: Outcome of VFS at 6 、12months with reference to baseline HFS

  5. Number of adverse events (AE's)

    Time frame: Change from Baseline to 6、12 Months

Sponsors and collaborators

Lead sponsor

Beijing Pins Medical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2015
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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