fMRI Connectivity in Fracture Hip Patients

NCT ID: NCT02997930

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-29

Study Completion Date

2019-05-06

Brief Summary

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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

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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.

Conditions

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Postoperative Delirium Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

fMRI

Intervention Type BEHAVIORAL

fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.

Montreal Cognitive Assessment (MoCA)

Intervention Type BEHAVIORAL

A measure of general cognition

Digital Clock Drawing Test Command and Copy

Intervention Type BEHAVIORAL

A measure of current cognition using digital pen technology

Wide Range Achievement Test reading subtest

Intervention Type BEHAVIORAL

A measure of premorbid intellectual estimate

Hopkins Verbal Learning Test (HVLT)

Intervention Type BEHAVIORAL

A measure of declarative memory

General Depression Scale (GDS)

Intervention Type BEHAVIORAL

A measure of the of presence of depression.

Interventions

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fMRI

fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.

Intervention Type BEHAVIORAL

Montreal Cognitive Assessment (MoCA)

A measure of general cognition

Intervention Type BEHAVIORAL

Digital Clock Drawing Test Command and Copy

A measure of current cognition using digital pen technology

Intervention Type BEHAVIORAL

Wide Range Achievement Test reading subtest

A measure of premorbid intellectual estimate

Intervention Type BEHAVIORAL

Hopkins Verbal Learning Test (HVLT)

A measure of declarative memory

Intervention Type BEHAVIORAL

General Depression Scale (GDS)

A measure of the of presence of depression.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramachandran Ramani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR18886

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201601806

Identifier Type: -

Identifier Source: org_study_id

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