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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601144
• Other study ID #: PINS-014
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2015
• Last updated: March 18, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Beijing Pins Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep Brain Stimulation
Deep Brain Stimulation

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital,Capital Medical University	Beijing	Beijing
China	Tsinghua University Yuquan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG) task	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.
Primary	the number of freezing episodes for TUG task	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	UPDRS III scores		Outcome of VFS at 6?12 months with reference to baseline HFS
Secondary	Gait and Falls Questionnaire (GFQ) scores		Outcome of VFS at 6?12 months with reference to baseline HFS
Secondary	the39-item Parkinson's Disease Questionnaire (PDQ-39) scores		Outcome of VFS at 6?12 months with reference to baseline HFS
Secondary	the Freezing of Gait Questionnaire (FOG-Q) scores		Outcome of VFS at 6 ?12months with reference to baseline HFS
Secondary	Number of adverse events (AE's)		Change from Baseline to 6?12 Months