Clinical Validity of the Minimally Conscious State "Plus" and "Minus"

July 13, 2023 updated by: Hospitales Nisa

Minimally Conscious State Plus Versus Minus: Likelihood of Emergence and Long-term Functional Independence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe acquired brain injuries can be caused by traumatic brain injury, stroke or anoxia, among others and can lead to Disorders of Consciousness (DOC), an umbrella term that encompasses a wide range of different clinical conditions such as coma, the Unresponsive Wakefulness Syndrome (UWS) and the Minimally Conscious State (MCS). Coma usually lasts from a few days to few weeks and it is defined as a state of profound unawareness from which the patient cannot be aroused; eyes are closed, and a normal sleep-wake cycle is absent. The UWS denotes a condition of wakefulness without (clinical signs of) awareness; UWS patients may open their eyes but exhibit only reflex (i.e. non-intentional) behaviors and are therefore considered unaware of themselves and their surroundings. On the other hand, the MCS denotes a condition where discernible behavioral evidence of consciousness is retained. More recently, given the heterogeneity of the MCS category, patients showing higher level responses, including reproducible movements to commands, intelligible verbalization and intentional communication (i.e. MCS+), have been distinguished from those showing lower level non-reflex responses (e.g. visual pursuit, object recognition; i.e. MCS-). Once patients recovery the ability to communicate or to use objects they are considered emerged from the MCS (EMCS).

Currently, the gold standard for the behavioural assessment of DOC patients is the Coma Recovery Scale-Revised (CRS-R) and the diagnosis is made according to the presence of certain behaviours. However, because of daily fluctuations, a minimum of 5 CRS-R evaluations within a short time interval are recommended, allowing to reduce the risk of misdiagnose to the 40%.

If the CRS-R criteria for the diagnosis of coma and UWS are somehow clear, the MCS and EMCS entities are the focus of a growing body of research. Despite all, the diagnostic criteria for DOC patients are becoming clearer and clearer, but markers to predict prognosis and functional outcome need to be better studied. Knowing the natural history of patients with DOC may help to an adequate prognosis, that is important not only for the patient and the family but also for treatment planning and provision of therapies and discharge. In particular, if there are existing studies about the prognosis of UWS and MCS patients, studies comparing MCS- and MCS+ patients are lacking. State of the art about the prognosis in DOC patients highlight a better outcome for patients in a MCS compared to patients in UWS, but little is known about a possible different prognosis between MCS+ and MCS- patients. A recent study stresses the need for prospective studies investigating differences in long-term functional outcome between patients in a MCS+ and MCS-. So far, the only available longitudinal study including MCS- and MCS+ patients followed 39 chronic DOC patient for two years after brain injury and assessed them with the CRS-R every 3 months. The sample included 16 patients in a UWS, 15 patients in a MCS-, 7 in a MCS+ and 1 in a EMCS and the authors did not find differences in the prognosis between MCS- and MCS+ patients, probably due to limited sample size.

Therefore, the first aim of this 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 total score. In particular, the investigators focus our attention on the likelihood of emergence from the MCS and on the evolution of functional independence after the emergence from the MCS. The investigators hypothesize that those patients presenting preferentially complex behavioural responses will have better clinical trajectories including an increasing likelihood to emerge form MCS and a better functional outcome once emerged from the MCS.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46011
        • Hospitales Nisa
      • Valencia, Spain, 46011
        • Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data of patients with DOC who had attended an inpatient neurorehabilitation program between January 2004 and December 2022 in all facilities of the hospital network.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients in a Minimally Conscious State
Patients diagnosed as in a Minimally Conscious State "Plus" and "Minus"
Behavioral: Rehabilitation
Physical therapy and multisensory stimulation adjusted to the needs of each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline clinical state
Time Frame: At admission to the rehabilitation hospital
Defined by the clinical state (Unresposive Wakefulness Syndrome, Minimally Conscious State, Emergence from Minimally Conscious State).
At admission to the rehabilitation hospital
Baseline neurobehavioral condition
Time Frame: At admission to the rehabilitation hospital

Defined by the score in the Coma Recovery Scale-Revised (CRS-R).

The CRS-R consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.
At admission to the rehabilitation hospital
Baseline disability
Time Frame: At the admission to the rehabilitation hospital

Defined by scores in the Disability Rating Scale (DRS).

The DRS is an 8-item scale that address the three original World Health Organization categories of impairment, disability and handicap. Scores obtained from the Disability Rating Scale can be interpreted as indicators of various levels of disability, including no disability (score of 0), mild (1), partial (2-3), moderate (4-6), moderately severe (7-11), severe (12-16), extremely severe (17-21), vegetative state (22-24), and extreme vegetative state (25-29).
At the admission to the rehabilitation hospital
Progress in the clinical state
Time Frame: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Defined by the clinical state (Unresposive Wakefulness Syndrome, Minimally Conscious State, Emergence from Minimally Conscious State).
Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Progress in the neurobehavioral condition
Time Frame: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months

Defined by the score in the Coma Recovery Scale-Revised (CRS-R).

The CRS-R consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.
Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Progress in disability
Time Frame: Monthly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months

Defined by scores in the Disability Rating Scale (DRS).

The DRS is an 8-item scale that address the three original World Health Organization categories of impairment, disability and handicap. Scores obtained from the Disability Rating Scale can be interpreted as indicators of various levels of disability, including no disability (score of 0), mild (1), partial (2-3), moderate (4-6), moderately severe (7-11), severe (12-16), extremely severe (17-21), vegetative state (22-24), and extreme vegetative state (25-29).
Monthly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Follow-up disability
Time Frame: At 6 months after emergence from MCS

Defined by scores in the Disability Rating Scale (DRS).

The DRS is an 8-item scale that address the three original World Health Organization categories of impairment, disability and handicap. Scores obtained from the Disability Rating Scale can be interpreted as indicators of various levels of disability, including no disability (score of 0), mild (1), partial (2-3), moderate (4-6), moderately severe (7-11), severe (12-16), extremely severe (17-21), vegetative state (22-24), and extreme vegetative state (25-29).
At 6 months after emergence from MCS
Follow-up independence in activities of daily living
Time Frame: At 6 months after emergence from MCS

Defined by scores in the Barthel Index (BI).

The BI measures the degree of assistance required by an individual on 10 items of mobility and self care. The scores in the BI can be interpreted as indicators of dependence, such as total dependence (scores below 21), severe dependence (21-60), moderate dependence (61-90), and slight dependence (scores above 90).
At 6 months after emergence from MCS
Follow-up functional Independence
Time Frame: At 6 months after emergence from MCS

Defined by scores in the Functional Independence Measure (FIM).

The FIM is a 18-item that measures independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. The total score of the FIM can be interpreted as a general measure of functional independence and also as stages of functional independence within activities of daily living, sphincter management, mobility, and executive function.
At 6 months after emergence from MCS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitales Nisa

Collaborators

Generalitat Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2004

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0428112022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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