Skip to main content
OpenTrials
Completed

NCT Number: NCT02997930

fMRI Connectivity in Fracture Hip Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Delirium Cognition Disorders Cognitive Dysfunction Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Dysfunction Postoperative Complications Signs and Symptoms

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fmri

Behavioral

fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.

MOntreal Cognitive Assessment (MoCA)

Behavioral

A measure of general cognition

Digital Clock Drawing Test Command and Copy

Behavioral

A measure of current cognition using digital pen technology

Wide Range Achievement Test reading subtest

Behavioral

A measure of premorbid intellectual estimate

Hopkins Verbal Learning Test (HVLT)

Behavioral

A measure of declarative memory

General Depression Scale (GDS)

Behavioral

A measure of the of presence of depression.

Primary outcomes

  1. 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

  1. Changes between baseline and follow up visits as assessed by MoCA

    Time frame: Change from baseline up to 90 days

    A measure of general cognition

  2. Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy

    Time frame: Change from baseline up to 90 days

    a measure of current cognition using digital pen technology

  3. Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest

    Time frame: Change from baseline up to 90 days

    A measure of premorbid intellectual estimate

  4. Changes between baseline and follow up visits as assessed by HVLT

    Time frame: Change from baseline up to 90 days

    A measure of declarative memory

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2016
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.