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临床试验/NCT01838824
NCT01838824已完成不适用

Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Change in scores on standardized tests of processing speed

研究概览

简要总结

This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with MS with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with MS utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the MS population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in MS could have a profound impact on the population and society as a whole.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

入选标准

  • Inclusions:
  • diagnosis of Multiple Sclerosis
  • fluent in English
  • processing speed impairment (based on evaluation).
  • Exclusions:
  • currently taking steroids and /or benzodiazepines
  • prior stroke or neurological disease
  • history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
  • significant alcohol or drug abuse history

排除标准

  • 未提供

结局指标

主要结局

Change in scores on standardized tests of processing speed

时间窗: Three points in time: Baseline (week 1), immediately following treatment (Group 1 - week 7, Group 2 - week 13), long-term follow-up (Group 1 - week 13, Group 2 - Week 19)

Standardized neuropsychological tests which be used will be used to determine whether there has been a change in speed of processing.

次要结局

未报告次要终点

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Chiaravalloti

Director, Neuropsychology & Neuroscience Lab

Kessler Foundation

研究点 (2)

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