fMRI Connectivity in Fracture Hip Patients

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction
• Intervention / Treatment: Behavioral: fMRI; Behavioral: Montreal Cognitive Assessment (MoCA); Behavioral: Digital Clock Drawing Test Command and Copy; Behavioral: Wide Range Achievement Test reading subtest; Behavioral: Hopkins Verbal Learning Test (HVLT); Behavioral: General Depression Scale (GDS)

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Elderly Hip Fracture; 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)

Behavioral: fMRI; fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.; Behavioral: Montreal Cognitive Assessment (MoCA); A measure of general cognition; Behavioral: Digital Clock Drawing Test Command and Copy; A measure of current cognition using digital pen technology; Behavioral: Wide Range Achievement Test reading subtest; A measure of premorbid intellectual estimate; Behavioral: Hopkins Verbal Learning Test (HVLT); A measure of declarative memory; Behavioral: General Depression Scale (GDS); A measure of the of presence of depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes between baseline and follow up visits as assessed by fMRI	fMRI for measuring function connectivity and DTI	Change from baseline up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes between baseline and follow up visits as assessed by MoCA	A measure of general cognition	Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy	a measure of current cognition using digital pen technology	Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest	A measure of premorbid intellectual estimate	Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by HVLT	A measure of declarative memory	Change from baseline up to 90 days

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Ramachandran Ramani, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2017
• Primary Completion (Actual): May 6, 2019
• Study Completion (Actual): May 6, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: IRB201601806; OCR18886 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No