fMRI Connectivity in Fracture Hip Patients

Study 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.

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

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)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly Hip Fracture<br>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<br>* fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.<br>Behavioral: Montreal Cognitive Assessment (MoCA)<br>* A measure of general cognition<br>Behavioral: Digital Clock Drawing Test Command and Copy<br>* A measure of current cognition using digital pen technology<br>Behavioral: Wide Range Achievement Test reading subtest<br>* A measure of premorbid intellectual estimate<br>Behavioral: Hopkins Verbal Learning Test (HVLT)<br>* A measure of declarative memory<br>Behavioral: General Depression Scale (GDS)<br>* A measure of the of presence of depression.<br>|

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 |