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临床试验/NCT03900702
NCT03900702Unknown不适用

Training Foundational Skills to Enhance Cognition in Older Adults

Jeanne Townsend, PhD2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
UFOV Attention Distraction

研究概览

简要总结

This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.

详细描述

This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.

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
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 60-80 years old
  • not demented
  • living independently; and (4) fluent in English.

排除标准

  • history of dementia, stroke, head injury involving loss of consciousness
  • current psychiatric or neurological disorders other than depression/anxiety

研究组 & 干预措施

Active Intervention

Active Comparator

Gaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing.

干预措施: Gaze-driven training games (Behavioral)

Wait List Control

No Intervention

Wait list then cross over to active intervention.

结局指标

主要结局

UFOV Attention Distraction

时间窗: 12 weeks

Subtest from Useful Field of View Task

UFOV Speed of Processing

时间窗: 12 weeks

Subtest from Useful Field of View Task

次要结局

  • Repeatable Battery for Neuropsychological Status (RBANS)(12 weeks)

研究者

发起方
Jeanne Townsend, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeanne Townsend, PhD

Professor Emeritus

University of California, San Diego

研究点 (2)

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