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临床试验/NCT02301260
NCT02301260已完成不适用

Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4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
100
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

The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life. This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.

详细描述

This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS. This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures. In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other. This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English as a primary language
  • diagnosis of Multiple Sclerosis
  • processing speed impairment (based on evaluation)

排除标准

  • most recent exacerbation within one month
  • currently taking steroids or benzodiazepines
  • history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
  • significant alcohol or drug abuse history

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 (week1), immediately following treatment (week 7) and 6 months after treatment is completed

次要结局

  • Change in scores on self-report of quality of life, measured via questionnaire(Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed)
  • Change in scores on self-report of emotional functioning, measured via questionnaire(Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed)
  • Change in scores on self-report of everyday functioning, measured via questionnaire(Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed)

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 and Neuroscience Laboratory

Kessler Foundation

研究点 (2)

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