Cognitive DysfunctionPRIMENCT03242395
PRIME: Cognitive Outcome Following Major Burns
An observational study of Cognitive Dysfunction and Burns, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging techniques, and that the neurocognitive deficit is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Burns, Inflammation, Brain
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Apr 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Severe burns survivors
Who may be able to join
- Invasive ventilation on a Burns Intensive Care Unit (BICU) within the previous ten years
- Burn injuries greater than 15% total body surface area (TBSA)
- Adult
Who cannot join
- Admission to BICU for other illnesses that were not burn related (such as Toxic Epidermal Necrolysis Syndrome)
- Evidence of head trauma
- Known substance misuse or alcohol excess
- Inability to understand plain verbal or written English
- Severe mental health issues
- Receiving formal psychiatric treatment
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- Currently held under the Mental Health Act
- If the subject's psychological health was deemed to be at risk from inclusion
- Imprisoned
- Contraindications to MRI
- non-compatible pacemakers
- surgical metalwork or foreign bodies
- severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
About this study
Official title: Perioperative Research Into Memory (PRiMe): The Use of fMRI to Investigate Neuroinflammation, Cognitive Dysfunction and Quality of Life Following a Major Burn Injury and Critical Care Admission
PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging techniques, and that the neurocognitive deficit is associated with a reduced quality of life.
Read the detailed description
Patients were matched with for age, sex and IQ (as determined by National Adult Reading Test scores) controlled volunteers.
Participants were assessed for the following domains: verbal ability, verbal and visual learning, short-term memory, working memory, executive function, attention and processing speed. The domains were assessed with the following validated cognitive tests: The Hopkins Verbal Learning Test, Trail making parts A and B, phonemic, semantic and switching verbal fluency as well as the Cogstate computerised battery: Identification speed, Detection speed, One Card Learning accuracy, One Back test accuracy, Two Back test accuracy, International Shopping List total correct answers and Groton Maze Learning total errors. Evidence of neuroinflammation was assessed using an fMRI protocol (Resting state MRI, T1w-MPR, T2 Space, Diffusion Tensor Imaging with 30 directions, right frontal white matter and posterior cingulate gyrus Single Voxel Spectroscopy, and patient group Susceptibility Weighted Imaging.
Quality of life was measured using the EuroQoL 5 Dimensions and visual analogue scale. Independent Activities of Daily Living was also assessed. Mental Health (as a confounder) was measured using the Patient Health Questionnaire 9, the Beck Depression Index II, the Beck Anxiety Inventory and the Trauma Screening Questionnaire.
Statistical methods include significant differences between the patient and control group using the Student t test (parametric data), the Mann Witney U test (non parametric data) or the Fisher's Exact test (qualitative scoring systems). MELODIC in FSL software was used to decompose the rs-fMRI data into brain networks using independent component analysis (ICA) and connectivity in these networks patients and controls was compared using dual regression. FreeSurfer was used to extract brain regions from T1 images and compare the normalised volume of the hippocampus, amygdala and precuneus for patients and controls. DTI data were analysed using tract based spatial statistics (TBSS) in FSL and using FreeSurfer regions for the hippocampus, amygdala and precuneus. Cho/Cr, Cho/NAA and Ins/Cr ratios were extracted from MRS data using Tarquin. SWI images were reviewed for the presence of microbleeds by two Radiologists.
- Conditions
- Cognitive Dysfunction, Burns, Inflammation, Brain, Quality of Life, Anxiety, Depression
- Keywords
- Neuroinflammation, fMRI, Post-operative cognitive dysfunction, Systemic inflammation, Severe burns
- Medical subject headings
- Cognitive Dysfunction, Burns, Encephalitis, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Burn patients | Adult survivors of severe burns who have been admitted to Burns ITU for invasive ventilation within 10 years of neurocognitive assessment | |
| Controls | Healthy volunteers, controlled for age/sex/IQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive deficit
Median T score of cognitive results (verbal ability, verbal and visual learning, short-term memory, working memory, executive function, attention and processing speed)
Measured: Within 10 years of injury
Secondary outcomes (2)
Quality of Life
EuroQoL 5D score
Measured: Within 10 years of injury
Neuroinflammation
As per the functional Magnetic Resonance Imaging protocol
Measured: Within 10 years of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startOct 2014
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Westminster, Imperial College Healthcare NHS Trust, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Marcela P Vizcaychipi, MD PhD, Principal investigator, Anaesthetic and Intensive Care Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242395
- Sponsor's protocol ID
- 14/LO/0049
- Acronym
- PRIME
- Status last verified
- Dec 2016
- First submitted
- 21 Apr 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Research Into Memory (PRiMe): The Use of fMRI to Investigate Neuroinflammation, Cognitive Dysfunction and Quality of Life Following a Major Burn Injury and Critical Care Admission
- ClinicalTrials.gov ID
- NCT03242395
- Acronym / sponsor ID
- PRIME / 14/LO/0049
- Conditions
- Cognitive Dysfunction, Burns, Inflammation, Brain, Quality of Life, Anxiety, Depression
- Keywords
- Neuroinflammation, fMRI, Post-operative cognitive dysfunction, Systemic inflammation, Severe burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Westminster, Imperial College Healthcare NHS Trust, Imperial College London
- Study start
- Oct 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Aug 2017 (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.
PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging techniques, and that the neurocognitive deficit is associated with a reduced quality of life.
Detailed description
Patients were matched with for age, sex and IQ (as determined by National Adult Reading Test scores) controlled volunteers.
Participants were assessed for the following domains: verbal ability, verbal and visual learning, short-term memory, working memory, executive function, attention and processing speed. The domains were assessed with the following validated cognitive tests: The Hopkins Verbal Learning Test, Trail making parts A and B, phonemic, semantic and switching verbal fluency as well as the Cogstate computerised battery: Identification speed, Detection speed, One Card Learning accuracy, One Back test accuracy, Two Back test accuracy, International Shopping List total correct answers and Groton Maze Learning total errors. Evidence of neuroinflammation was assessed using an fMRI protocol (Resting state MRI, T1w-MPR, T2 Space, Diffusion Tensor Imaging with 30 directions, right frontal white matter and posterior cingulate gyrus Single Voxel Spectroscopy, and patient group Susceptibility Weighted Imaging.
Quality of life was measured using the EuroQoL 5 Dimensions and visual analogue scale. Independent Activities of Daily Living was also assessed. Mental Health (as a confounder) was measured using the Patient Health Questionnaire 9, the Beck Depression Index II, the Beck Anxiety Inventory and the Trauma Screening Questionnaire.
Statistical methods include significant differences between the patient and control group using the Student t test (parametric data), the Mann Witney U test (non parametric data) or the Fisher's Exact test (qualitative scoring systems). MELODIC in FSL software was used to decompose the rs-fMRI data into brain networks using independent component analysis (ICA) and connectivity in these networks patients and controls was compared using dual regression. FreeSurfer was used to extract brain regions from T1 images and compare the normalised volume of the hippocampus, amygdala and precuneus for patients and controls. DTI data were analysed using tract based spatial statistics (TBSS) in FSL and using FreeSurfer regions for the hippocampus, amygdala and precuneus. Cho/Cr, Cho/NAA and Ins/Cr ratios were extracted from MRS data using Tarquin. SWI images were reviewed for the presence of microbleeds by two Radiologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn patients | – | –Adult survivors of severe burns who have been admitted to Burns ITU for invasive ventilation within 10 years of neurocognitive assessment |
| Controls | – | –Healthy volunteers, controlled for age/sex/IQ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Severe burns survivors
Key inclusion criteria (3 listed)
- Invasive ventilation on a Burns Intensive Care Unit (BICU) within the previous ten years
- Burn injuries greater than 15% total body surface area (TBSA)
- Adult
Key exclusion criteria (13 listed)
- Admission to BICU for other illnesses that were not burn related (such as Toxic Epidermal Necrolysis Syndrome)
- Evidence of head trauma
- Known substance misuse or alcohol excess
- Inability to understand plain verbal or written English
- Severe mental health issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurocognitive deficit
Time frame: Within 10 years of injury
Median T score of cognitive results (verbal ability, verbal and visual learning, short-term memory, working memory, executive function, attention and processing speed)
2 secondary outcomes
Quality of Life
Time frame: Within 10 years of injury
Neuroinflammation
Time frame: Within 10 years of injury
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 8 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Marcela P Vizcaychipi, MD PhD principal investigator
Anaesthetic and Intensive Care Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Burns, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 13 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 8 Aug 2017. 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 Kingdom. 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?
Neurocognitive deficit (time frame: Within 10 years of injury). 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 8 Aug 2017.