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fMRI Connectivity in Fracture Hip Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02997930
Enrollment
2
Registered
2016-12-20
Start date
2017-01-29
Completion date
2019-05-06
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium, Postoperative Cognitive Dysfunction

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.

Interventions

BEHAVIORALfMRI

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

A measure of general cognition

BEHAVIORALDigital Clock Drawing Test Command and Copy

A measure of current cognition using digital pen technology

BEHAVIORALWide Range Achievement Test reading subtest

A measure of premorbid intellectual estimate

BEHAVIORALHopkins Verbal Learning Test (HVLT)

A measure of declarative memory

BEHAVIORALGeneral Depression Scale (GDS)

A measure of the of presence of depression.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes between baseline and follow up visits as assessed by fMRIChange from baseline up to 90 daysfMRI for measuring function connectivity and DTI

Secondary

MeasureTime frameDescription
Changes between baseline and follow up visits as assessed by MoCAChange from baseline up to 90 daysA measure of general cognition
Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and CopyChange from baseline up to 90 daysa measure of current cognition using digital pen technology
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtestChange from baseline up to 90 daysA measure of premorbid intellectual estimate
Changes between baseline and follow up visits as assessed by HVLTChange from baseline up to 90 daysA measure of declarative memory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026