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

NCT02601144 | Completed Phase 1 DMC

• 1 other identifier: PINS-014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson's Disease

Keywords

DBS; VFS; FOG

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• UPDRS III scores

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

• Gait and Falls Questionnaire (GFQ) scores

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

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

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

• the Freezing of Gait Questionnaire (FOG-Q) scores

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

• Number of adverse events (AE's)

  Change from Baseline to 6、12 Months

Study Arms (4)

VFS

EXPERIMENTAL

variable frequency deep brain stimulation (VFS)

Device: Deep Brain Stimulation

HFS

ACTIVE COMPARATOR

high frequency deep brain stimulation (HFS)

Device: Deep Brain Stimulation

LFS

ACTIVE COMPARATOR

low frequency deep brain stimulation (LFS)

Device: Deep Brain Stimulation

DBS off

NO INTERVENTION

deep brain stimulation off

Interventions

Deep Brain Stimulation DEVICE

Deep Brain Stimulation

HFS; LFS; VFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

Study Sites (2)

Tsinghua University Yuquan Hospital

Beijing, Beijing Municipality, 100040, China

Location

Beijing Tian Tan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Luming Li, Ph.D

  Tsinghua University

  STUDY CHAIR

• Michael Okun, MD.

  University of Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 10, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

CN (2)