Clinical trial NCT02601144: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: DBS
VFS
FOG
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Timed Up and Go (TUG) task
timeFrame: The outcome of TUG task at 12 months follow-up.
measure: the number of freezing episodes for TUG task
timeFrame: The outcome of TUG task at 12 months follow-up.
Secondary outcomes:
measure: UPDRS III scores
timeFrame: Outcome of VFS at 6、12 months with reference to baseline HFS
measure: Gait and Falls Questionnaire (GFQ) scores
timeFrame: Outcome of VFS at 6、12 months with reference to baseline HFS
measure: the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
timeFrame: Outcome of VFS at 6、12 months with reference to baseline HFS
measure: the Freezing of Gait Questionnaire (FOG-Q) scores
timeFrame: Outcome of VFS at 6 、12months with reference to baseline HFS
measure: Number of adverse events (AE's)
timeFrame: Change from Baseline to 6、12 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua University Yuquan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tian Tan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Luming Li, Ph.D
role: STUDY_CHAIR
affiliation: University of Florida
name: Michael Okun, MD.
role: STUDY_CHAIR
References: