CompletedNot Applicable

PRIME: Cognitive Outcome Following Major Burns

United Kingdom30 participantsStarted 2014-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neurocognitive deficit

Timeframe: Within 10 years of injury

Trial details

NCT IDNCT03242395

SponsorChelsea and Westminster NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-02

View on ClinicalTrials.gov More Cognitive Dysfunction trials