Freezing of Gait: Clinical, Cognitive, and Imaging Features
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
研究概览
简要总结
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.
详细描述
This study is an observational study to assess FOG via using multiple methods such as: clinical features, imaging, cognition and dopamine blood levels. The study consists of four parts (plus an optional fifth part) that will be completed over two-three separate days within a 30 day span. The four parts will not necessarily be performed in this order. Part one will be clinical and written questionnaire assessments of PD and FOG followed by 3D motion capture evaluations. Part two are cognitive or neuropsychiatric assessments. Part three is a magnetic resonance image (MRI) to examine the brain structure. Part four is Positron Emission Tomography (PET) imaging scan that measures norepinephrine transporter levels. The optional part 5 is a lumbar puncture that will measure cerebrospinal fluid catecholamines and proteomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
时间窗: Baseline
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.
Plasma concentrations of levodopa
时间窗: Baseline
Levodopa plasma concentrations measured by modified high-performance liquid chromatography with electrochemical detection method during "on" and "off" episodes.
Response to levodopa
时间窗: Baseline
Subjects will be assessed in the "on" and "off" states to classify them properly according to pharmacological response to levodopa
Classification of FOG using motion capture
时间窗: Baseline
Classifying of FOG ("on" and "off") will be done measuring gait physiology though 3-dimensional motion capture between and during FOG episodes.
次要结局
- Flanker task score(Baseline)
- N-back task score(Baseline)
- Digit Span Test score(Baseline)
- Number of seconds required to complete Trail Making Test (TMT): Trails A and Trails B(Baseline)
- Wisconsin Card Sorting Test (WCST) score(Baseline)
- Number of correct trials in Morris Water Maze Paradigm(Baseline)
- Number of correct trials in Recognition of Scenes(Baseline)
- Dimensional Set Shifting task score(Baseline)
- Brief Visuospatial Memory Test score(Baseline)
- Number of correct responses for Mental Rotation Task(Baseline)
- Scale for the Assessment of Positive Symptoms (SAPS) score(Baseline)
- Measurement of norepinephrine transporter levels(Baseline)
- Montreal Cognitive Assessment (MoCA) score(Baseline)
- Hopkins Verbal Memory Test Total Recall score(Baseline)
- Beck Anxiety Inventory (BAI) score(Baseline)
- Questionnaire for Impulsive-Compulsive disorders in Parkinson's disease (QUIP)(Baseline)
- Dot Counting task score(Baseline)
- Hopkins Verbal Memory Test Delayed Recall score(Baseline)
- Number of correct responses for Confrontation Naming task(Baseline)
- Verbal Fluency in Naming Categories(Baseline)
- Benton Judgment of Line Orientation Test(Baseline)
- Beck Depression Inventory (BDI) score(Baseline)
- New Freezing of Gait Questionnaire (NFOG-Q) score(Baseline)
- Measurement of neuromelanin-containing neurons in the locus ceruleus and substantia nigra(Baseline)
- Cerebrospinal fluid (CSF) biomarkers(Baseline)