An observational study in Major Injury, sponsored by Chelsea and Westminster NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational
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Among 13 studies in Cognition Disorders with a site in United Kingdom — none open to participants now, 1 under way, none of them phase 3. Cognition Disorders · United Kingdom.
Among the 13 studies in Cognition Disorders with a site in United Kingdom, this one is the only one that started in 2015, is one of 6 observational ones, and was the 9th registered.
399 studies on the registry are indexed under Cognition Disorders; 73 are open to participants now.
Browse Cognition Disorders studies →None of the 13 studies in Cognition Disorders with a site in United Kingdom is open now. The open studies under Cognition Disorders, anywhere →
Of the 46 Cognition Disorders studies recruiting now, 20 (43%) set no upper age limit and 11 (24%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 16 Years and older · all sexes · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2015.
This study's enrollment of 32 is below the median of 137 across 108 observational studies indexed under Cognition Disorders.
Median enrollment 120 across the 7 interventional studies, 266 across the 6 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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3 of 13 have an industry lead sponsor. The 10 most frequent:
Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Chelsea and Westminster NHS Foundation Trust has 1 study filed under Cognition Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies in Cognition Disorders with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03507257Indiana UniversityLongitudinal Early-onset Alzheimer's Disease Study Protocol | 2027-01-01 |
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Among the 13 studies in Cognition Disorders with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Patients with severe burn injury admitted to a Burn Intensive Care Unit
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Psychological screening · Other: fMRI · Behavioral: Quality of Life Self-Assessment data
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 · Behavioral: Psychological screening · Other: fMRI · Behavioral: Quality of Life Self-Assessment data
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 · Behavioral: Psychological screening · Other: fMRI · Behavioral: Quality of Life Self-Assessment data
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 · Behavioral: Psychological screening · Other: fMRI · Behavioral: Quality of Life Self-Assessment data
Assessment of attention, processing speed, working memory and executive function
Also known as: - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised battery
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Also known as: - Patient health questionnaire (PHQ9), - Generalised anxiety (GAD7) scoring systems, - Trauma screening questionnaire
Brain volume, chemical markers, functional outcome
Also known as: 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
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Also known as: - EQ-5D
Neurocognitive function
Specifically to investigate cognitive tasks using a battery of computerised tests.
Time frame: 5 years
Neuroinflammatory changes analysis.
Functional MRI scan
Time frame: 5 years
Long-term quality of Life
EQ-5D
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2015 to primary completion in Apr 2016, 8 months.
Of 43 non-industry observational studies under Cognition Disorders, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 89. This study's 8 months is below that.
Counting every sponsor, half of 44 studies reached it within 41 months; a quarter within 13 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Chelsea and Westminster NHS Foundation Trust