fMRI Connectivity in Fracture Hip Patients

Not Applicable

Completed

• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction
• Interventions: 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)

• Registration Number: NCT02997930
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Study Start: 2017-01-29
• Primary Completion: 2019-05-06
• Study Completion: 2019-05-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Patients 65 years and older
• Patients who have fracture hip and are anticipated to have surgery

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elderly Hip Fracture	Digital Clock Drawing Test Command and Copy	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)
Elderly Hip Fracture	Wide Range Achievement Test reading subtest	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)
Elderly Hip Fracture	Montreal Cognitive Assessment (MoCA)	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)
Elderly Hip Fracture	Hopkins Verbal Learning Test (HVLT)	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)
Elderly Hip Fracture	fMRI	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)
Elderly Hip Fracture	General Depression Scale (GDS)	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)

Primary Outcome Measures

Name	Time	Method
Changes between baseline and follow up visits as assessed by fMRI	Change from baseline up to 90 days	fMRI for measuring function connectivity and DTI

Secondary Outcome Measures

Name	Time	Method
Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy	Change from baseline up to 90 days	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	Change from baseline up to 90 days	A measure of premorbid intellectual estimate
Changes between baseline and follow up visits as assessed by MoCA	Change from baseline up to 90 days	A measure of general cognition
Changes between baseline and follow up visits as assessed by HVLT	Change from baseline up to 90 days	A measure of declarative memory

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States