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

Beijing Pins Medical

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601144

PINS-014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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28 participants in 4 patient groups

VFS

Experimental group

Description:

variable frequency deep brain stimulation (VFS)

Treatment:

Device: Deep Brain Stimulation

HFS

Active Comparator group

Description:

high frequency deep brain stimulation (HFS)

Treatment:

Device: Deep Brain Stimulation

LFS

Active Comparator group

Description:

low frequency deep brain stimulation (LFS)

Treatment:

Device: Deep Brain Stimulation

DBS off

No Intervention group

Description:

deep brain stimulation off