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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02997930
Other study ID # IRB201601806
Secondary ID OCR18886
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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