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

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ClinicalTrials.gov Identifier: NCT03470844
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
University of Westminster
Information provided by (Responsible Party):
Marcela P. Vizcaychipi, Chelsea and Westminster NHS Foundation Trust

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Major Injury Behavioral: Face-to-face neurocognitive tests Behavioral: Psychological screening Other: fMRI Behavioral: Quality of Life Self-Assessment data

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 Design
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Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury
Actual Study Start Date : August 5, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Memory

Groups and Cohorts
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: - 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 Name: - 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 Name: - 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 Name: - EQ-5D


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive function [ Time Frame: 5 years ]
    Specifically to investigate cognitive tasks using a battery of computerised tests.


Secondary Outcome Measures :
  1. Neuroinflammatory changes analysis. [ Time Frame: 5 years ]
    Functional MRI scan


Other Outcome Measures:
  1. Long-term quality of Life [ Time Frame: 5 years ]
    EQ-5D


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe burn injury admitted to a Burn Intensive Care Unit
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470844


Locations
Layout table for location information
United Kingdom
The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
University of Westminster
Investigators
Layout table for investigator information
Study Chair: Marcela Vizcaychipi, MD PhD FRCA Chelsea and Westminster Hospital
More Information
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Layout table for additonal information
Responsible Party: Marcela P. Vizcaychipi, Planned Care Surgery & Clinical Support Divisional Research Lead, Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03470844    
Other Study ID Numbers: C&W13/099
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcela P. Vizcaychipi, Chelsea and Westminster NHS Foundation Trust:
Major burns
Intensive Care Medicine
Neurocognitive dysfunction
 Functional magnetic resonance imaging
Neuroinflammation
Long term quality of life