Cognitive Assessment Tools for Individuals With Huntington's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Symbol Digit Modality Test (SDMT) compared to the Coding Test
研究概览
简要总结
The purpose of the current proposal is to expand understanding of two currently available cognitive tools that are not typically used in Huntington Disease (HD) clinical trials that might be useful both for initial screening and for clinical trial application. One is the Coding Test and the other is the Self-Administered Gerocognitive Examination (SAGE). Both the Coding Test and the SAGE have been used for assessments of individuals with other neurodegenerative diseases, including Alzheimer's Disease, Parkinson's Disease and Lewy Body Disease, but data is lacking on their use in individuals with HD.
详细描述
Subjects will be recruited from the OSU Wexner Medical Center Huntington Society of America Center of Excellence Clinic. Subjects will be scheduled for a one-time visit to complete the study. The entire visit will take approximately 1-1.5 hours. Vital signs (weight, blood pressure, temperature, respiratory rate and pulse) will be conducted. The subject's medical records will be reviewed to obtain their demographics, current medications, medical/surgical/ HD family history, and HD diagnosis details. If any adverse events occur during the research visit they will be documented. Participants will complete cognitive, functional and motor assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 30-65 (inclusive) at the time of signing the informed consent form.
- •Genetic diagnosis of HD as defined by a CAG repeat size ≥
- •A clinical diagnosis of HD as defined by a Diagnostic Confidence Level (DCL) of
- •Vision and hearing sufficient for compliance with tests.
- •On a stable dose of medications for 30 days prior to the time of signing the informed consent form.
排除标准
- •Age of symptom onset less than 19 years old or greater than 60 years old.
- •Any serious neurological disorder aside from HD, including but not limited to Alzheimer's disease, Parkinson's disease, Frontotemporal dementia, Lewy body dementia, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury… etc. that in the opinion of the investigator is clinically significant.
- •Any ongoing serious medical condition that in the opinion of the investigator is clinically significant. This includes autoimmune diseases, ongoing treatment for cancer, congestive heart failure, severe pulmonary disease, or any history of a seizure disorder (including the need to take anti-epileptics to prevent seizure).
- •Subjects who are pregnant or breast feeding
- •Subjects with a history of a learning disability.
- •Subjects who are unable to provide consent.
研究组 & 干预措施
Subject population
All subjects who meet the inclusion/exclusion criteria for the trial.
干预措施: Assessments (Behavioral)
结局指标
主要结局
Symbol Digit Modality Test (SDMT) compared to the Coding Test
时间窗: One day visit
Comparison of scores on Symbol Digit Modality Test (SDMT) and Coding Test. Associations will be investigated using Spearman correlations.
Self-Administered Gerocognitive Examination (SAGE) score compared to the Symbol Digit Modality Test (SDMT) and the Stroop Word reading scores
时间窗: One day visit
Comparison of SAGE score with the SDMT and the Stroop Word reading scores. (The two neuropsychological scores used in the UHDRS that have shown the best correlation with HD disease onset and progression). Associations will be investigated using Spearman correlations.
次要结局
- Comparison of Luria test scores and Symbol Digit Modality Test (SDMT) vs Coding scores.(One day visit)
- Comparison of Total Motor Chorea sub-score, a part of the Unified Huntington's Disease Rating Scale (UHDRS) total score and scores on the Symbol Digit Modality Test (SDMT), Coding and Self-Administered Gerocognitive Examination (SAGE).(One day visit)
- Correlation of age of HD symptom onset and SAGE scores(One day visit)
研究者
Sandra Kostyk
Clinical Professor of Neurology
Ohio State University