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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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VFS

variable frequency deep brain stimulation (VFS)

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation

HFS

high frequency deep brain stimulation (HFS)

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation

LFS

low frequency deep brain stimulation (LFS)

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation

DBS off

deep brain stimulation off

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep Brain Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No