NCT01335633已完成不适用
Psychometric Validation of Cognitive Endpoints
Kessler Foundation4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
研究概览
简要总结
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old (inclusive).
- •History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
- •Physically able to see the testing materials and complete the tests
- •Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.
排除标准
- •A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
- •Untreated major depression or untreated anxiety disorder.
- •History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
- •History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
- •A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
- •History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day
- •Active bacterial or viral infection.
- •Use of marijuana within 2 months prior to Study Day 1or at any time during the study
- •Alcohol consumption within 24 hours of either test session.
- •Unable to comply with study requirements.
- •Expected survival time of less than 3 months.
研究者
John DeLuca
Vice President of Research
Kessler Foundation
研究点 (4)
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