Clinical Validity of the Minimally Conscious State "Plus" and "Minus" (NCT05954650) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validity of the Minimally Conscious State "Plus" and "Minus"
Spain80 participantsStarted 2004-09-30
Plain-language summary
The goal of this observational retrospective study is to investigate and compare the clinical evolution of a sample of patients with the diagnosis of MCS+ versus MCS- according to the CRS-R. The main questions it aims to answer are the presence of differences in the likelihood of emergence from the MCS (EMCS) between these two groups and in the progress of disability and functional independence after the EMCS.
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:
* Severe acquired brain injury leading to a Disorder of Consciousness (DOC)
* Persistance of the DOC for a period not inferior to 28 days and not longer than 6 months
* Diagnosis of MCS
* Having a fa follow-up period of no less than 12 months from the onset
Exclusion Criteria:
* Diagnosis of UWS
* Being younger than 18 years
* DOC persisting more than 6 months
* Absence of follow-up
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
1
Baseline clinical state
Timeframe: At admission to the rehabilitation hospital
2
Baseline neurobehavioral condition
Timeframe: At admission to the rehabilitation hospital
3
Baseline disability
Timeframe: At the admission to the rehabilitation hospital
4
Progress in the clinical state
Timeframe: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
5
Progress in the neurobehavioral condition
Timeframe: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
6
Progress in disability
Timeframe: Monthly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months