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fMRI Connectivity in Fracture Hip Patients

Primary Purpose

Postoperative Delirium, Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fMRI
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)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Delirium

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly Hip Fracture

Arm Description

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)

Outcomes

Primary Outcome Measures

Changes between baseline and follow up visits as assessed by fMRI
fMRI for measuring function connectivity and DTI

Secondary Outcome Measures

Changes between baseline and follow up visits as assessed by MoCA
A measure of general cognition
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
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
A measure of premorbid intellectual estimate
Changes between baseline and follow up visits as assessed by HVLT
A measure of declarative memory

Full Information

First Posted
December 16, 2016
Last Updated
August 9, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02997930
Brief Title
fMRI Connectivity in Fracture Hip Patients
Official Title
Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2017 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly Hip Fracture
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
fMRI
Intervention Description
fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.
Intervention Type
Behavioral
Intervention Name(s)
Montreal Cognitive Assessment (MoCA)
Intervention Description
A measure of general cognition
Intervention Type
Behavioral
Intervention Name(s)
Digital Clock Drawing Test Command and Copy
Intervention Description
A measure of current cognition using digital pen technology
Intervention Type
Behavioral
Intervention Name(s)
Wide Range Achievement Test reading subtest
Intervention Description
A measure of premorbid intellectual estimate
Intervention Type
Behavioral
Intervention Name(s)
Hopkins Verbal Learning Test (HVLT)
Intervention Description
A measure of declarative memory
Intervention Type
Behavioral
Intervention Name(s)
General Depression Scale (GDS)
Intervention Description
A measure of the of presence of depression.
Primary Outcome Measure Information:
Title
Changes between baseline and follow up visits as assessed by fMRI
Description
fMRI for measuring function connectivity and DTI
Time Frame
Change from baseline up to 90 days
Secondary Outcome Measure Information:
Title
Changes between baseline and follow up visits as assessed by MoCA
Description
A measure of general cognition
Time Frame
Change from baseline up to 90 days
Title
Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy
Description
a measure of current cognition using digital pen technology
Time Frame
Change from baseline up to 90 days
Title
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
Description
A measure of premorbid intellectual estimate
Time Frame
Change from baseline up to 90 days
Title
Changes between baseline and follow up visits as assessed by HVLT
Description
A measure of declarative memory
Time Frame
Change from baseline up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramachandran Ramani, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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fMRI Connectivity in Fracture Hip Patients

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