Magnetic Resonance ImagingNCT05081726
fMRI Feasibility Older Hip Fracture Surgery
An observational study of Magnetic Resonance Imaging and Hip Fractures, run by University of Nottingham.
Trial summary
An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Magnetic Resonance Imaging, Hip Fractures, Postoperative Delirium
- What is being tested?
- Functional MRI
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2022to 6 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older people recovering from hip fracture surgery
Who may be able to join
- Age ≥ 65 years
- Cognitively intact
- primary admission for hip fracture surgery
Who cannot join
- Cognitive impairment
- Less than moderate level of activities of daily living
- History of neurosurgery/significant head trauma
- Acutely unwell/moribund
- Presence of neurological diseases including overt stroke, dementia, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders.
- Postural or movement disorders likely to impede MRI scan
- Contraindications to MRI
- Complex fractures/multiple injuries
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Functional MRI in Older People Following Hip Fracture Surgery: a Feasibility Study
An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery
Read the detailed description
Postoperative delirium, an acute sate of confusion occurs with higher frequency in older people. Hip fracture surgery is a procedure associated with an increased risk of postoperative delirium.
In the study the feasibility of achieving structure and functional connectivity imaging of the brain, using magnetic resonance imaging, in older people who are recovering from hip fracture surgery will be assessed.
People who have recovered from post operative delirium and people who did not have postoperative delirium will be included.
- Being tested
- Functional MRI
- Keywords
- older people, postoperative delirium, Functional MRI
- Medical subject headings
- Hip Fractures, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIDiagnostic test
Series of MRI scans of the brain
| Study group | Role | What they receive |
|---|---|---|
| Never had delirium | Older people recovering from hip fracture surgery who did not have postoperative delirium Receives: Diagnostic Test: Functional MRI | |
| Recovered delirium | Older people recovering from hip fracture surgery who experienced delirium which has resolved Receives: Diagnostic Test: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process
The feasibility of transferring participants to and achieving structural and functional MRI scans. Specifically we will assess the number of participants in whom scans were successfully achieved
Measured: From time of consent to day after MRI scan which is up to 5 days
Secondary outcomes (4)
Abnormalities of functional connectivity
Identify any differences in functional connectivity between the resolved delirium and the never delirium MRI scans
Measured: Up to one month after scans have been achieved
Pain assessment.
An assessment of baseline pain levels and then repeat assessments of pain during transfer and the MRI scanning process using the numerical pain rating scale
Measured: From immediately prior to transfer to the MRI suite until return to own hospital bed which is approximately 2 hours
Actual times taken to achieve scans
An assessment of unforeseen constraints on time taken to scan
Measured: Up to 60 minutes
Participant feedback
The participant experience will be explored via verbal feedback which will be documented by the accompanying researcher
Measured: Two occassions. The first immediately after return from the MRI scan suite. The second will occur the day after scanning. Each will take 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start4 Jul 2022 (estimated)
- Primary completion2 Sep 2022 (estimated)
- Study completion6 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Dineen, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081726
- Sponsor's protocol ID
- 19087
- Status last verified
- May 2022
- First submitted
- 28 Feb 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Incidental findings in participants who give consent for sharing of these with their physician, will be communicated to the general practitioner for further action if required.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI in Older People Following Hip Fracture Surgery: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05081726
- Acronym / sponsor ID
- 19087
- Keywords
- older people, postoperative delirium, Functional MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 4 Jul 2022 (estimated)
- Primary completion
- 2 Sep 2022 (estimated)
- Study completion
- 6 Dec 2022 (estimated)
- First posted
- 18 Oct 2021 (actual)
- 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.
An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery
Detailed description
Postoperative delirium, an acute sate of confusion occurs with higher frequency in older people. Hip fracture surgery is a procedure associated with an increased risk of postoperative delirium.
In the study the feasibility of achieving structure and functional connectivity imaging of the brain, using magnetic resonance imaging, in older people who are recovering from hip fracture surgery will be assessed.
People who have recovered from post operative delirium and people who did not have postoperative delirium will be included.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Never had delirium | – | Diagnostic Test: Functional MRIOlder people recovering from hip fracture surgery who did not have postoperative delirium |
| Recovered delirium | – | Diagnostic Test: Functional MRIOlder people recovering from hip fracture surgery who experienced delirium which has resolved |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older people recovering from hip fracture surgery
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Cognitively intact
- primary admission for hip fracture surgery
Key exclusion criteria (8 listed)
- Cognitive impairment
- Less than moderate level of activities of daily living
- History of neurosurgery/significant head trauma
- Acutely unwell/moribund
- Presence of neurological diseases including overt stroke, dementia, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders.
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 |
|---|---|---|
| Functional MRISeries of MRI scans of the brain | Diagnostic test | Never had delirium, Recovered delirium |
Primary outcome
Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process
Time frame: From time of consent to day after MRI scan which is up to 5 days
The feasibility of transferring participants to and achieving structural and functional MRI scans. Specifically we will assess the number of participants in whom scans were successfully achieved
4 secondary outcomes
Abnormalities of functional connectivity
Time frame: Up to one month after scans have been achieved
Pain assessment.
Time frame: From immediately prior to transfer to the MRI suite until return to own hospital bed which is approximately 2 hours
Actual times taken to achieve scans
Time frame: Up to 60 minutes
Participant feedback
Time frame: Two occassions. The first immediately after return from the MRI scan suite. The second will occur the day after scanning. Each will take 5 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided. Incidental findings in participants who give consent for sharing of these with their physician, will be communicated to the general practitioner for further action if required.
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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.
Rob Dineen, PhD principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging and Hip Fractures, run by University of Nottingham.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abiodun Moronke Noah, FRCA (01158231011, abi.noah@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process (time frame: From time of consent to day after MRI scan which is up to 5 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 6 May 2022.