Understand FoG in PD: Behavioral Physiology and Clinical Application
NCT ID: NCT02987140
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
SINGLE
Study Groups
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PD+FoG
PD patients with FoG
Clinical evaluations
Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.
PD-FoG
PD patients without FoG
Clinical evaluations
Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.
Control
age-matched non-disabled adults
Clinical evaluations
Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.
Interventions
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Clinical evaluations
Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.
Eligibility Criteria
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Inclusion Criteria
* Healthy control subjects
Exclusion Criteria
* have other neurological diseases other than PD
* have pacemaker implanted in their body
* have a history of seizure
* have a family history of epilepsy
18 Years
ALL
Yes
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ya-Yun Lee, PHD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ya-Yun Lee, PHD
Role: primary
Other Identifiers
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201606057RINA
Identifier Type: -
Identifier Source: org_study_id