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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

Outcome Measure
Measure Description
Time Frame
Neuroinflammatory changes analysis.
Time Frame: 5 years
Functional MRI scan
5 years

Other Outcome Measures

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

Chelsea and Westminster NHS Foundation Trust

Collaborators

Imperial College Healthcare NHS Trust
University of Westminster

Investigators

  • 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)

August 5, 2015

Primary Completion (ACTUAL)

April 30, 2016

Study Completion (ACTUAL)

October 30, 2017

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

March 19, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Major Injury

Clinical Trials on Face-to-face neurocognitive tests

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe