fMRI Connectivity in Fracture Hip Patients

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997930
• Other study ID #: IRB201601806
• Secondary ID: OCR18886
• Status: Completed
• Phase: N/A
• Start date: January 29, 2017
• Est. completion date: May 6, 2019

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes between baseline and follow up visits as assessed by MoCA	A measure of general cognition	Change from baseline up to 90 days
Secondary	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
Secondary	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
Secondary	Changes between baseline and follow up visits as assessed by HVLT	A measure of declarative memory	Change from baseline up to 90 days