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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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