Perioperative Research Into Memory: Cognitive Outcome Following Major Burns (PRiMe)

March 19, 2018 updated by: Marcela P. Vizcaychipi, Chelsea and Westminster NHS Foundation Trust

Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury

The long term survival of patients who require admission to critical care (CC) following a major burn injury (MBI) continues to improve with advanced clinical management. There has been increasing interest into cognitive dysfunction (CD) due to neuroinflammation (NI) following CC, anaesthesia, surgery, and the association of NI with diseases characterised by CD such as Alzheimer's disease. Patients who suffer a MBI and who subsequently require admission to CC will be at uniquely high risk for CD. MBI produces an exaggerated and prolonged systemic inflammatory response, with NI demonstrated in animal models. Additionally NI can be exaggerated by insults such as sepsis, anaesthesia, and surgical trauma, common and often necessary following MBI. The aim of this study is to identify CD using cognitive tests to examine for deficits in working memory and executive function. Test proposed to use are the Hopkins Verbal Learning and Verbal Fluency tests, and a validated computerised battery (CogState). Neuroinflammation and underlying pathophysiology using fMRI and spectroscopy, known to demonstrate biomarkers for CD and NI. QoL will be assessed using the validated EQ-5D tool.

The Inclusion criteria; patients who survive their burns injury (greater than 15% total body surface area) and require mechanical ventilation. Primary exclusion criteria; admission with toxic epidermal necrolysis syndrome, and evidence of head trauma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a novel, proof of principle, prospective, cohort design, observational clinical study to assess for functional brain reorganisation, structural changes and long-term cognitive dysfunction following major burns injury and intensive care admission. The hypothesis is that following a major burns injury and intensive care admission patients will have neurocognitive dysfunction and demonstrable functional alterations seen on functional MRI due to neuroinflammation as a result of the primary injury and subsequent inflammatory insults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe burn injury admitted to a Burn Intensive Care Unit

Description

Inclusion Criteria:

  • Survival following admission to Chelsea and Westminster Burns Intensive Care Unit between 2004-2013 with a burn injury > 15% total body surface area, requiring intubation and ventilation

Exclusion Criteria:

  • Patients under 16.
  • Patients with toxic epidermal necrolysis syndrome or evidence of head trauma.
  • Patients with evidence of risk to psychological safety from inclusion in study: any patient currently held under section of the Mental Health Act, any patient receiving formal psychiatric treatment (including involvement in a Personality Disorder Unit, being under voluntary section, current re-occurrence of chronic self harm), any patient currently detained at her Majesty's pleasure, any current substance abuse, or at the discretion of professional opinion following historical assessment of notes. - Patients with contraindications to MRI (patients with non-compatible pacemakers, patients with metallic foreign bodies e.g. metal sliver in their eye, patients with non-compatible surgical metal work, patients with severe claustrophobia).
  • Patient refusal or inability to give full informed consent.
  • Patients unable to understand plain verbal or written English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
5-10 years post severe burn injury

Interventions:

  • Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function.
  • Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire.
  • fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL.
  • Quality of Life Self-Assessment data.
Behavioral: Face-to-face neurocognitive tests
Assessment of attention, processing speed, working memory and executive function
Other Names:
  • - Hopkins Verbal Learning and Verbal Fluency tests
  • - CogState computerised battery
Behavioral: Psychological screening
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Other Names:
  • - Patient health questionnaire (PHQ9)
  • - Generalised anxiety (GAD7) scoring systems
  • - Trauma screening questionnaire
Other: fMRI
Brain volume, chemical markers, functional outcome
Other Names:
  • The functional MRI (fMRI) protocol includes:
  • - Resting state fMRI
  • - T1w-mpr, T2w-FLAIR
  • - Diffusion Tensor Imaging (DTI)
  • - Spectroscopy
  • - Double inversion recovery (DIR) and Perfusion ASL
Behavioral: Quality of Life Self-Assessment data
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Other Names:
  • - EQ-5D
2-5 years post severe burn injury

Interventions:

  • Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function.
  • Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire.
  • fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL.
  • Quality of Life Self-Assessment data.
Behavioral: Face-to-face neurocognitive tests
Assessment of attention, processing speed, working memory and executive function
Other Names:
  • - Hopkins Verbal Learning and Verbal Fluency tests
  • - CogState computerised battery
Behavioral: Psychological screening
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Other Names:
  • - Patient health questionnaire (PHQ9)
  • - Generalised anxiety (GAD7) scoring systems
  • - Trauma screening questionnaire
Other: fMRI
Brain volume, chemical markers, functional outcome
Other Names:
  • The functional MRI (fMRI) protocol includes:
  • - Resting state fMRI
  • - T1w-mpr, T2w-FLAIR
  • - Diffusion Tensor Imaging (DTI)
  • - Spectroscopy
  • - Double inversion recovery (DIR) and Perfusion ASL
Behavioral: Quality of Life Self-Assessment data
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Other Names:
  • - EQ-5D
1-2 years post severe burn injury

Interventions:

  • Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function.
  • Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire.
  • fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL.
  • Quality of Life Self-Assessment data.
Behavioral: Face-to-face neurocognitive tests
Assessment of attention, processing speed, working memory and executive function
Other Names:
  • - Hopkins Verbal Learning and Verbal Fluency tests
  • - CogState computerised battery
Behavioral: Psychological screening
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Other Names:
  • - Patient health questionnaire (PHQ9)
  • - Generalised anxiety (GAD7) scoring systems
  • - Trauma screening questionnaire
Other: fMRI
Brain volume, chemical markers, functional outcome
Other Names:
  • The functional MRI (fMRI) protocol includes:
  • - Resting state fMRI
  • - T1w-mpr, T2w-FLAIR
  • - Diffusion Tensor Imaging (DTI)
  • - Spectroscopy
  • - Double inversion recovery (DIR) and Perfusion ASL
Behavioral: Quality of Life Self-Assessment data
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Other Names:
  • - EQ-5D
Control

Healthy age, gender, socioeconomic and educational level matched control.

Interventions:

  • Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function.
  • Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire.
  • fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL.
  • Quality of Life Self-Assessment data.
Behavioral: Face-to-face neurocognitive tests
Assessment of attention, processing speed, working memory and executive function
Other Names:
  • - Hopkins Verbal Learning and Verbal Fluency tests
  • - CogState computerised battery
Behavioral: Psychological screening
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Other Names:
  • - Patient health questionnaire (PHQ9)
  • - Generalised anxiety (GAD7) scoring systems
  • - Trauma screening questionnaire
Other: fMRI
Brain volume, chemical markers, functional outcome
Other Names:
  • The functional MRI (fMRI) protocol includes:
  • - Resting state fMRI
  • - T1w-mpr, T2w-FLAIR
  • - Diffusion Tensor Imaging (DTI)
  • - Spectroscopy
  • - Double inversion recovery (DIR) and Perfusion ASL
Behavioral: Quality of Life Self-Assessment data
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Other Names:
  • - EQ-5D

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurocognitive function
Time Frame: 5 years
Specifically to investigate cognitive tasks using a battery of computerised tests.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuroinflammatory changes analysis.
Time Frame: 5 years
Functional MRI scan
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term quality of Life
Time Frame: 5 years
EQ-5D
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chelsea and Westminster NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Imperial College Healthcare NHS Trust
University of Westminster

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marcela Vizcaychipi, MD PhD FRCA, Chelsea and Westminster Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C&W13/099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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