NCT02997930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

December 16, 2016

Last Update Submit

August 9, 2019

Conditions

Postoperative DeliriumPostoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes between baseline and follow up visits as assessed by MoCA

    Change from baseline up to 90 days

  • Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy

    Change from baseline up to 90 days

  • Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest

    Change from baseline up to 90 days

  • Changes between baseline and follow up visits as assessed by HVLT

    Change from baseline up to 90 days

Study Arms (1)

Elderly Hip Fracture

EXPERIMENTAL

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)

Behavioral: fMRIBehavioral: Montreal Cognitive Assessment (MoCA)Behavioral: Digital Clock Drawing Test Command and CopyBehavioral: Wide Range Achievement Test reading subtestBehavioral: Hopkins Verbal Learning Test (HVLT)Behavioral: General Depression Scale (GDS)

Interventions

fMRIBEHAVIORAL

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

Elderly Hip Fracture
Montreal Cognitive Assessment (MoCA)BEHAVIORAL

A measure of general cognition

Elderly Hip Fracture
Digital Clock Drawing Test Command and CopyBEHAVIORAL

A measure of current cognition using digital pen technology

Elderly Hip Fracture
Wide Range Achievement Test reading subtestBEHAVIORAL

A measure of premorbid intellectual estimate

Elderly Hip Fracture
Hopkins Verbal Learning Test (HVLT)BEHAVIORAL

A measure of declarative memory

Elderly Hip Fracture
General Depression Scale (GDS)BEHAVIORAL

A measure of the of presence of depression.

Elderly Hip Fracture

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Emergence DeliriumPostoperative Cognitive Complications

Interventions

Mental Status and Dementia TestsDNA Replication

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersCognitive DysfunctionCognition Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesBiochemical PhenomenaChemical PhenomenaGenetic Phenomena

Study Officials

  • Ramachandran Ramani, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 20, 2016

Study Start

January 29, 2017

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)