Postoperative DeliriumNCT02997930
fMRI Connectivity in Fracture Hip Patients
A study testing fMRI, Montreal Cognitive Assessment (MoCA) and Digital Clock Drawing Test Command and Copy in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- fMRI, Montreal Cognitive Assessment (MoCA) and Digital Clock Drawing Test Command and Copy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2017to 6 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years and older
- Patients who have fracture hip and are anticipated to have surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients
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.
Read the 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.
- Being tested
- fMRI, Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT)
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIBehavioural
fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.
Montreal Cognitive Assessment (MoCA)Behavioural
A measure of general cognition
Digital Clock Drawing Test Command and CopyBehavioural
A measure of current cognition using digital pen technology
Wide Range Achievement Test reading subtestBehavioural
A measure of premorbid intellectual estimate
Hopkins Verbal Learning Test (HVLT)Behavioural
A measure of declarative memory
General Depression Scale (GDS)Behavioural
A measure of the of presence of depression.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between baseline and follow up visits as assessed by fMRI
fMRI for measuring function connectivity and DTI
Measured: Change from baseline up to 90 days
Secondary outcomes (4)
Changes between baseline and follow up visits as assessed by MoCA
A measure of general cognition
Measured: Change from baseline up to 90 days
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
Measured: Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
A measure of premorbid intellectual estimate
Measured: Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by HVLT
A measure of declarative memory
Measured: Change from baseline up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start29 Jan 2017
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramachandran Ramani, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997930
- Sponsor's protocol ID
- IRB201601806
- Other IDs
- OCR18886
- Status last verified
- Aug 2019
- First submitted
- 16 Dec 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients
- ClinicalTrials.gov ID
- NCT02997930
- Acronym / sponsor ID
- IRB201601806
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 Jan 2017 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Hip Fracture | Experimental | 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)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) |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients 65 years and older
- Patients who have fracture hip and are anticipated to have surgery
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIfMRI for measuring function connectivity and DTI will be done between day 2 to day 5. | Behavioural | Elderly Hip Fracture |
| Montreal Cognitive Assessment (MoCA)A measure of general cognition | Behavioural | Elderly Hip Fracture |
| Digital Clock Drawing Test Command and CopyA measure of current cognition using digital pen technology | Behavioural | Elderly Hip Fracture |
| Wide Range Achievement Test reading subtestA measure of premorbid intellectual estimate | Behavioural | Elderly Hip Fracture |
| Hopkins Verbal Learning Test (HVLT)A measure of declarative memory | Behavioural | Elderly Hip Fracture |
| General Depression Scale (GDS)A measure of the of presence of depression. | Behavioural | Elderly Hip Fracture |
Primary outcome
Changes between baseline and follow up visits as assessed by fMRI
Time frame: Change from baseline up to 90 days
fMRI for measuring function connectivity and DTI
4 secondary outcomes
Changes between baseline and follow up visits as assessed by MoCA
Time frame: Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy
Time frame: Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
Time frame: Change from baseline up to 90 days
Changes between baseline and follow up visits as assessed by HVLT
Time frame: Change from baseline up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramachandran Ramani, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Montreal Cognitive Assessment (MoCA) and Digital Clock Drawing Test Command and Copy in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes between baseline and follow up visits as assessed by fMRI (time frame: Change from baseline up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.