Understand FoG in PD: Behavioral Physiology & Clinical Application

Status Recruiting

Clinical Trial Summary

The overall goals of this proposed study are to investigate the behavioral and neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing freezing of gait (FoG). More specifically, we aim to determine the behavioral changes in context-dependency and changes in corticomotor excitability associated with FoG.

Clinical Trial Description

Background: Freezing of gait (FoG) is a debilitating symptom for patients with Parkinson's disease (PD). FoG not only impairs walking but also significantly increase fall risks and decrease quality of life for patients with PD. Despite the critical consequences, the mechanisms associated with this phenomenon are not well understood.

Clinically, FoG often occurs when individuals with PD are approaching a narrow pathway or crossing a busy street. This observation leads to the hypothesis that FoG is associated with context-dependent motor performance, a phenomenon that an individual demonstrate poorer performance if the learned motor task is carried out in an unfamiliar context. Whether the occurrence of freezing episodes is a result of context-dependency has not been systematically investigated. Moreover, the changes in corticomotor excitability associated with FoG have not been well-established.

Objectives: The objectives of this proposal are to understand the behavioral and neurophysiological mechanisms of FoG. The specific aim is to examine the behavioral changes in context-dependency and changes in corticomotor excitability associated with FoG.

Methods: a total of 70 participants, including PD patients with FoG, PD patients without FoG, and age-matched non-disabled adults, will be recruited. The participants will undergo behavioral and neurophysiological examinations. Behavioral evaluations will include context-dependent motor performance, FoG, disease severity, and walking and balance functions. Transcranial magnetic stimulation and electroencephalogram will be used to measure corticomotor excitability of the participants. Analysis of variance (ANOVA) and regression analysis will be performed to compare and determine the relationship between FoG, behavioral outcomes, and corticomotor excitability. Statistical significance level is set at p < 0.05. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02987140
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Ya-Yun Lee, PHD
Phone	886-2-33668155
Email	yayunlee@ntu.edu.tw
Status	Recruiting
Phase	N/A
Start date	December 2016
Completion date	December 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Understand FoG in PD: Behavioral Physiology and Clinical Application

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms