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临床试验/NCT04966000
NCT04966000撤回不适用

Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment

University of Utah2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
12
试验地点
2
主要终点
Catherine Bergego Scale

研究概览

简要总结

Preliminary data will be collected about which individuals with spatial neglect from right hemisphere stroke (aiming vs perceptual neglect) improve with Prism Adaptation Training and if there is a particular pattern of damage in the brain that predicts both the type of neglect experienced and whether neglect is improved following Prism Adaptation Training

详细描述

For preliminary data, twelve individuals with right hemisphere stroke and spatial neglect will participate. After pretesting for type of neglect and its severity, they will have an MRI with Diffusion Tensor Imaging (DTI). Then they will complete 10 sessions of Prism Adaptation Therapy and complete neglect post-testing. Response to Prism Adaptation Therapy will be assessed by comparing neglect scores pre- and post-training. Traditional lesion mapping, structural and functional lesion disconnectivity analyses, and tract-based spatial statistics of DTI measures will be used to examine whether any patterns of damage/dysfunction are related to a diagnosis of aiming neglect and response to Prism Adaptation Therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • within 1 month of right hemisphere stroke
  • suspected of having unilateral spatial neglect
  • able to provide consent
  • likely to remain in rehabilitation for 10-12 days or willing to return to the University to complete 10 sessions of treatment and post-treatment testing
  • able to have an MRI
  • will be or has been admitted to the Craig H. Neilson Rehabilitation Hospital for rehabilitation or is able to come to the Craig H. Neilson Rehabilitation Hospital for prism adaptation therapy sessions.
  • age 18-90 years
  • able to sit in a wheelchair or other chair for 1 hour
  • able to point straight ahead and hold a pen with right hand

排除标准

  • other neurologic, medical that would interfere with ability to complete the testing or training
  • no uncorrected visual or hearing problems, other than hemianopsia
  • contraindications to MRI
  • unable to provide consent due to significant aphasia or cognitive impairment

结局指标

主要结局

Catherine Bergego Scale

时间窗: post-intervention immediately after prism adaptation therapy

asks the impact of neglect behavior on 20 everyday tasks using a 0-3 rating scale. Higher scores = more neglect impact. Total score is sum of item scores

次要结局

  • Behavioral Attention Test conventional subtests(post-intervention immediately after prism adaptation therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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