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Clinical Trials/NCT02997930
NCT02997930
Completed
N/A

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

University of Florida1 site in 1 country2 target enrollmentJanuary 29, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
University of Florida
Enrollment
2
Locations
1
Primary Endpoint
Changes between baseline and follow up visits as assessed by fMRI
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 29, 2017
End Date
May 6, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Changes between baseline and follow up visits as assessed by fMRI

Time Frame: Change from baseline up to 90 days

fMRI for measuring function connectivity and DTI

Secondary Outcomes

  • 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)

Study Sites (1)

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