Disorder of ConsciousnessNCT05954650
Clinical Validity of the Minimally Conscious State "Plus" and "Minus"
An observational study of Disorder of Consciousness, run by Hospitales Nisa at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Sep 2004to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Diagnosis of UWS
- Being younger than 18 years
- DOC persisting more than 6 months
- Absence of follow-up
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospitales NISA
Valencia, 46011
Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA
Valencia, 46011
About this study
Official title: 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.
Read the 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.
- Conditions
- Disorder of Consciousness
- Being tested
- Rehabilitation
- Keywords
- Disorders of Consciousness, Minimally Conscious State, Minimally Conscious State Plus, Minimally Conscious State Minus, Disability Rating Scale, Functional Independence
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Physical therapy and multisensory stimulation adjusted to the needs of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients in a Minimally Conscious State | Patients diagnosed as in a Minimally Conscious State "Plus" and "Minus" Receives: Behavioral: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline clinical state
Defined by the clinical state (Unresposive Wakefulness Syndrome, Minimally Conscious State, Emergence from Minimally Conscious State).
Measured: At admission to the rehabilitation hospital
Baseline neurobehavioral condition
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.
Measured: At admission to the rehabilitation hospital
Baseline disability
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).
Measured: At the admission to the rehabilitation hospital
Progress in the clinical state
Defined by the clinical state (Unresposive Wakefulness Syndrome, Minimally Conscious State, Emergence from Minimally Conscious State).
Measured: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Progress in the neurobehavioral condition
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.
Measured: Weekly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Progress in disability
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).
Measured: Monthly assessments from admission to the rehabilitation hospital to discharge, demise, or emergence from MCS, up to 36 months
Follow-up disability
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).
Measured: At 6 months after emergence from MCS
Follow-up independence in activities of daily living
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).
Measured: At 6 months after emergence from MCS
Follow-up functional Independence
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.
Measured: At 6 months after emergence from MCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start30 Sep 2004
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Nisa
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954650
- Sponsor's protocol ID
- P0428112022
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bareham CA, Allanson J, Roberts N, Hutchinson PJA, Pickard JD, Menon DK, Chennu S. Longitudinal assessments highlight long-term behavioural recovery in disorders of consciousness. Brain Commun. 2019;1(1):fcz017. doi: 10.1093/braincomms/fcz017. Epub 2019 Sep 16.
PubMed 31886461Bruno MA, Vanhaudenhuyse A, Thibaut A, Moonen G, Laureys S. From unresponsive wakefulness to minimally conscious PLUS and functional locked-in syndromes: recent advances in our understanding of disorders of consciousness. J Neurol. 2011 Jul;258(7):1373-84. doi: 10.1007/s00415-011-6114-x. Epub 2011 Jun 16.
PubMed 21674197Bruno MA, Majerus S, Boly M, Vanhaudenhuyse A, Schnakers C, Gosseries O, Boveroux P, Kirsch M, Demertzi A, Bernard C, Hustinx R, Moonen G, Laureys S. Functional neuroanatomy underlying the clinical subcategorization of minimally conscious state patients. J Neurol. 2012 Jun;259(6):1087-98. doi: 10.1007/s00415-011-6303-7. Epub 2011 Nov 12.
PubMed 22081100Colantonio A, Gerber G, Bayley M, Deber R, Yin J, Kim H. Differential profiles for patients with traumatic and non-traumatic brain injury. J Rehabil Med. 2011 Mar;43(4):311-5. doi: 10.2340/16501977-0783.
PubMed 21347507Katz DI, Polyak M, Coughlan D, Nichols M, Roche A. Natural history of recovery from brain injury after prolonged disorders of consciousness: outcome of patients admitted to inpatient rehabilitation with 1-4 year follow-up. Prog Brain Res. 2009;177:73-88. doi: 10.1016/S0079-6123(09)17707-5.
PubMed 19818896Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
PubMed 11839831Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
PubMed 15605342Golden K, Erler KS, Wong J, Giacino JT, Bodien YG. Should Consistent Command-Following Be Added to the Criteria for Emergence From the Minimally Conscious State? Arch Phys Med Rehabil. 2022 Sep;103(9):1870-1873. doi: 10.1016/j.apmr.2022.03.010. Epub 2022 Apr 6.
PubMed 35398046MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Pape TL, Lundgren S, Heinemann AW, Guernon A, Giobbie-Hurder A, Wang J, Roth H, Blahnik M, Williams V. Establishing a prognosis for functional outcome during coma recovery. Brain Inj. 2006 Jun;20(7):743-58. doi: 10.1080/02699050600676933.
PubMed 16809207Rappaport M, Hall KM, Hopkins K, Belleza T, Cope DN. Disability rating scale for severe head trauma: coma to community. Arch Phys Med Rehabil. 1982 Mar;63(3):118-23.
PubMed 7073452Song M, Yang Y, Yang Z, Cui Y, Yu S, He J, Jiang T. Prognostic models for prolonged disorders of consciousness: an integrative review. Cell Mol Life Sci. 2020 Oct;77(20):3945-3961. doi: 10.1007/s00018-020-03512-z. Epub 2020 Apr 18.
PubMed 32306061Stineman MG, Ross RN, Fiedler R, Granger CV, Maislin G. Functional independence staging: conceptual foundation, face validity, and empirical derivation. Arch Phys Med Rehabil. 2003 Jan;84(1):29-37. doi: 10.1053/apmr.2003.50061.
PubMed 12589617Thibaut A, Bodien YG, Laureys S, Giacino JT. Minimally conscious state "plus": diagnostic criteria and relation to functional recovery. J Neurol. 2020 May;267(5):1245-1254. doi: 10.1007/s00415-019-09628-y. Epub 2019 Nov 26.
PubMed 31773246Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.
PubMed 28543735
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Conscious State Plus Versus Minus: Likelihood of Emergence and Long-term Functional Independence
- ClinicalTrials.gov ID
- NCT05954650
- Acronym / sponsor ID
- P0428112022
- Conditions
- Disorder of Consciousness
- Keywords
- Disorders of Consciousness, Minimally Conscious State, Minimally Conscious State Plus, Minimally Conscious State Minus, Disability Rating Scale, Functional Independence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospitales NisaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana
- Study start
- 30 Sep 2004 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in a Minimally Conscious State | – | Behavioral: RehabilitationPatients diagnosed as in a Minimally Conscious State "Plus" and "Minus" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis of UWS
- Being younger than 18 years
- DOC persisting more than 6 months
- Absence of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationPhysical therapy and multisensory stimulation adjusted to the needs of each patient. | Behavioural | Patients in a Minimally Conscious State |
Primary outcome
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).
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.
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).
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).
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.
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).
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 31886461Bareham CA, Allanson J, Roberts N, Hutchinson PJA, Pickard JD, Menon DK, Chennu S. Longitudinal assessments highlight long-term behavioural recovery in disorders of consciousness. Brain Commun. 2019;1(1):fcz017. doi: 10.1093/braincomms/fcz017. Epub 2019 Sep 16.
- Background: PubMed 21674197Bruno MA, Vanhaudenhuyse A, Thibaut A, Moonen G, Laureys S. From unresponsive wakefulness to minimally conscious PLUS and functional locked-in syndromes: recent advances in our understanding of disorders of consciousness. J Neurol. 2011 Jul;258(7):1373-84. doi: 10.1007/s00415-011-6114-x. Epub 2011 Jun 16.
- Background: PubMed 22081100Bruno MA, Majerus S, Boly M, Vanhaudenhuyse A, Schnakers C, Gosseries O, Boveroux P, Kirsch M, Demertzi A, Bernard C, Hustinx R, Moonen G, Laureys S. Functional neuroanatomy underlying the clinical subcategorization of minimally conscious state patients. J Neurol. 2012 Jun;259(6):1087-98. doi: 10.1007/s00415-011-6303-7. Epub 2011 Nov 12.
- Background: PubMed 21347507Colantonio A, Gerber G, Bayley M, Deber R, Yin J, Kim H. Differential profiles for patients with traumatic and non-traumatic brain injury. J Rehabil Med. 2011 Mar;43(4):311-5. doi: 10.2340/16501977-0783.
- Background: PubMed 19818896Katz DI, Polyak M, Coughlan D, Nichols M, Roche A. Natural history of recovery from brain injury after prolonged disorders of consciousness: outcome of patients admitted to inpatient rehabilitation with 1-4 year follow-up. Prog Brain Res. 2009;177:73-88. doi: 10.1016/S0079-6123(09)17707-5.
- Background: PubMed 11839831Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
- Background: PubMed 15605342Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
- Background: PubMed 35398046Golden K, Erler KS, Wong J, Giacino JT, Bodien YG. Should Consistent Command-Following Be Added to the Criteria for Emergence From the Minimally Conscious State? Arch Phys Med Rehabil. 2022 Sep;103(9):1870-1873. doi: 10.1016/j.apmr.2022.03.010. Epub 2022 Apr 6.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 16809207Pape TL, Lundgren S, Heinemann AW, Guernon A, Giobbie-Hurder A, Wang J, Roth H, Blahnik M, Williams V. Establishing a prognosis for functional outcome during coma recovery. Brain Inj. 2006 Jun;20(7):743-58. doi: 10.1080/02699050600676933.
- Background: PubMed 7073452Rappaport M, Hall KM, Hopkins K, Belleza T, Cope DN. Disability rating scale for severe head trauma: coma to community. Arch Phys Med Rehabil. 1982 Mar;63(3):118-23.
- Background: PubMed 32306061Song M, Yang Y, Yang Z, Cui Y, Yu S, He J, Jiang T. Prognostic models for prolonged disorders of consciousness: an integrative review. Cell Mol Life Sci. 2020 Oct;77(20):3945-3961. doi: 10.1007/s00018-020-03512-z. Epub 2020 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness, run by Hospitales Nisa at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline clinical state (time frame: At admission to the rehabilitation hospital). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05954650, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.