NCT02387281|CompletedDMC
Freezing of Gait: Clinical, Cognitive, and Imaging Features
FOG
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FOG
Sponsor study identifier
observational
60
1 country
2
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 13, 2017
Actual (reported)Study Completion
November 13, 2017
Actual (reported)Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD) and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting \<30 seconds) episode of absence or a greatly reduced forward movement of the feet despite intention to walk. It typically occurs when patients initiate gait (so-called "start hesitation") and when attempting to turn. It is a leading cause of falls and often results in a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes social isolation and poor quality of life. FOG is one of the least understood features of PD. It possibly may develop independent of the other motor features of the disease, and be caused by specific pathological changes in the brain. Previous studies on FOG have shown conflicting information and have not lead to clear understanding of the pathophysiology. One key reason for this is that there appears to be multiple subtypes which have rarely been taken into account. The purpose of this study is to show that different types of FOG exist and to see if there is a connection to cognitive differences or gait patterns.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 6, 2015
Actual (reported)March 12, 2015
Actual (reported)November 13, 2017
Actual (reported)November 13, 2017
Actual (reported)Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The Part III motor examination has 18 items, which are rated from 0-4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Baseline
Response to levodopa
Subjects will be assessed in the "on" and "off" states to classify them properly according to pharmacological response to levodopa
Baseline
Classification of FOG using motion capture
Classifying of FOG ("on" and "off") will be done measuring gait physiology though 3-dimensional motion capture between and during FOG episodes.
Baseline
Plasma concentrations of levodopa
Levodopa plasma concentrations measured by modified high-performance liquid chromatography with electrochemical detection method during "on" and "off" episodes.
Baseline
Dot Counting task score
Baseline
N-back task score
Baseline
Flanker task score
Baseline
Dimensional Set Shifting task score
Baseline
Digit Span Test score
Baseline
Subjects diagnosed with Parkinson disease (PD) and sub-categorized as "on" freezing of gait (FOG) based on evaluation using motion capture
Subjects diagnosed with Parkinson disease (PD) and sub-categorized as "off" freezing of gait (FOG) based on evaluation using motion capture
Subjects with Parkinson disease (PD) and an absence of freezing of gait (FOG)
Subjects with freezing of gait (FOG) and an absence of Parkinson disease (PD) (exception granted for those with FOG and atypical parkinsonism: PSP or MSA)
Freezing of gait (FOG) patients with Parkinson disease (PD) will be selected from the Emory Movement Disorders Center.
Emory Movement Disorders Center
Atlanta, Georgia, 30329, United States
Wesley Woods Center
Atlanta, Georgia, 30329, United States
Plasma
Stewart Factor, DO
Emory University
60 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2015
First Posted
March 12, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Uncovering an Electrical Biomarker for Freezing of Gait in Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
November 13, 2017
Actual (reported)Study Completion
November 13, 2017
Actual (reported)Last Updated
April 6, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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