Depression Clinical Trial
— PRIMEOfficial 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
Verified date | December 2016 |
Source | Chelsea and Westminster NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Chelsea and Westminster NHS Foundation Trust | Imperial College Healthcare NHS Trust, Imperial College London, University of Westminster |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Within 10 years of injury | |
Secondary | Quality of Life | EuroQoL 5D score | Within 10 years of injury | |
Secondary | Neuroinflammation | As per the functional Magnetic Resonance Imaging protocol | Within 10 years of injury |
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