Clinical trial NCT02987140: Understand FoG in PD: Behavioral Physiology and Clinical Application
Official title: Understand Freezing of Gait in Parkinson's Disease: Behavioral Physiology and Clinical Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Keywords: Parkinson's disease
freezing of gait
context-dependency
transcranial magnetic stimulation
visual cues
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-12-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion criteria:

* Individuals with Parkinson's disease
* Healthy control subjects

Exclusion criteria:

* unable to follow the instructions
* have other neurological diseases other than PD
* have pacemaker implanted in their body
* have a history of seizure
* have a family history of epilepsy

Primary outcomes:
measure: New Freezing of Gait Questionnaire (NFOG-Q)
timeFrame: 30 mins
measure: Context-dependent behavior
timeFrame: 40 mins
Secondary outcomes:
measure: The Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 30 mins
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 10 mins
measure: The Stroop Color-Word test
timeFrame: 5 mins
measure: 10-Meter Walk Test (10MWT)
timeFrame: 5 mins
measure: The Timed Up and Go (TUG) test
timeFrame: 5 mins
measure: The Parkinson's Disease Questionnaire(PDQ-39)
timeFrame: 10 mins
measure: Transcranial magnetic stimulation
timeFrame: 45 mins
measure: Electroencephalogram (EEG)
timeFrame: 40 mins
measure: The short FoG and festination assessment score
timeFrame: 20 mins
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Ya-Yun Lee, PHD
role: PRINCIPAL_INVESTIGATOR
References: