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临床试验/NCT02997930
NCT02997930已完成不适用

Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients

University of Florida2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Changes between baseline and follow up visits as assessed by fMRI

研究概览

简要总结

The long-term goal of this study is to evaluate cognitive function preoperatively and develop techniques of intervention in the perioperative period which would optimize brain function and functional recovery following surgery.

详细描述

In this protocol, subjects who are anticipated to be operated for hip fracture will be studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean diffusivity) data will be compared with age matched controls and correlated with subjective measures of cognition.

研究设计

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

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 65 years and older
  • Patients who have fracture hip and are anticipated to have surgery

排除标准

  • Patients who have contraindications for MRI like pacemaker, automatic implanted cardiac defibrillator (AICD), implanted infusion pumps etc.
  • Patients who are claustrophobic
  • Patients with severe cognitive impairment (who may not be able to cooperate during the cognitive exam and fMRI)

研究组 & 干预措施

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: fMRI (Behavioral)

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: Montreal Cognitive Assessment (MoCA) (Behavioral)

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: Digital Clock Drawing Test Command and Copy (Behavioral)

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: Wide Range Achievement Test reading subtest (Behavioral)

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: Hopkins Verbal Learning Test (HVLT) (Behavioral)

Elderly Hip Fracture

Experimental

Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)

干预措施: General Depression Scale (GDS) (Behavioral)

结局指标

主要结局

Changes between baseline and follow up visits as assessed by fMRI

时间窗: Change from baseline up to 90 days

fMRI for measuring function connectivity and DTI

次要结局

  • Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy(Change from baseline up to 90 days)
  • Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest(Change from baseline up to 90 days)
  • Changes between baseline and follow up visits as assessed by MoCA(Change from baseline up to 90 days)
  • Changes between baseline and follow up visits as assessed by HVLT(Change from baseline up to 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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