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临床试验/NCT06238492
NCT06238492招募中不适用

Intervening Quickly: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

Kessler Foundation6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
6
主要终点
Symbol Digit Modalities Test (SDMT)

研究概览

简要总结

This study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.

详细描述

Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.

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
Quadruple (Participant, Care Provider, 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

  • 18-59 years old
  • recent traumatic SCI (approximately 6 months post-injury)

排除标准

  • no other significant neurological, psychiatric or substance use history
  • no significantly impairing visual disturbance

结局指标

主要结局

Symbol Digit Modalities Test (SDMT)

时间窗: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

processing speed task, matching numbers to symbols using a key

Letter & Pattern Comparison (LPC)

时间窗: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

processing speed task, using both letter and pattern strings

Useful Field of View (UFOV)

时间窗: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

computerized processing speed task

次要结局

  • Spinal Cord Injury Quality of Life scales(baseline to immediate post-treatment (week 13) and long-term follow-up (week 25))

研究者

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

Erica Weber

Research Scientist

Kessler Foundation

研究点 (6)

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