Disorder of ConsciousnessCRS-R_InfoNCT05819177
Information of the Coma Recovery Scale-Revised for Neurobehavioral State and Recovery of Consciousness Prediction
An observational study of Disorder of Consciousness, run by Hospitales Nisa at 2 sites in Spain.
Trial summary
Background: The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument to examine the neurobehavioral condition of individuals with disorders of consciousness (DOCs). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Rehabilitation program
- How many people
- 171 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2004to 31 Dec 2021
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with Disorder Of Consciousness (DOC) who had attended an inpatient neurorehabilitation program between February 2004 and December 2021 in three facilities of the same hospital network were retrospectively extracted from their medical records.
Who may be able to join
- diagnosis with (Unresponsive Wakefulness Syndrome) UWS or Minimal Consciousness State (MCS) due to either a vascular, anoxic or traumatic origin
Who cannot join
- individuals who did not attended the program for at least three months
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: An Analysis of the Information of the Coma Recovery Scale-Revised Providing the Most Reliable Prediction of the Neurobehavioral State and Recovery of Consciousness
Background: The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument to examine the neurobehavioral condition of individuals with disorders of consciousness (DOCs). Different studies have investigated the prognostic value of the information provided by the conventional administration of the scale, while other measures derived from the scale have been proposed to improve the prognosis of DOCs. However, the heterogeneity of the data used in the different studies prevents a reliable comparison of the identified predictors and measures.
Objectives: This study investigates which information derived from the CRS-R provides the most reliable prediction of both the neurobehavioral state and recovery of consciousness at the discharge of a long-term neurorehabilitation program.
Methods: The clinical records of 171 individuals with DOCs admitted to an inpatient neurorehabilitation program for a minimum of 3 months were used to implement machine learning classifiers that were trained to predict the neurobehavioral state and recovery of consciousness at discharge.
Read the detailed description
Severe acquired brain injury, understood as any damage to the brain that causes coma for over 24 hours, can lead to a complex clinical condition characterized by impaired consciousness, commonly referred to as a disorder of consciousness (DOC). The concept of consciousness is multifaceted and complex and arises from the presence of both arousal, i.e. vigilance and wakefulness, and awareness, i.e. perception of the environment and self. Consequently, depending on the presence and nature of the behavioral responses to multisensory stimuli, individuals with DOC are diagnosed as either in an unresponsive wakefulness syndrome (UWS) or vegetative state (VS) if they only show reflexes, or in a minimally conscious state (MCS) if they show intentional responses. Two further subgroups have been proposed within this latter group that allow to categorize individuals in an MCS+ or in an MCS- according to the presence or absence of higher-level behaviors, respectively. Finally, individuals who show functional communication or functional use of objects are considered as emerging from the MCS.
Diagnosis of DOCs, therefore, poses a clinical challenge, as it requires the accurate analysis of behavioral signs that can be weak or inconsistent. The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument worldwide for assessing the neurobehavioral condition of individuals with DOC and features multiple cross-cultural adaptations. The CRS-R investigates the presence of 23 neurobehavioral responses, grouped in 6 different subscales, which evaluate auditory, visual, motor, oromotor, communication, and arousal functions. For each subscale, the responses are hierarchically ordered and are evaluated from higher responses (cognitively-mediated responses) to lower responses (reflexes). The diagnostic utility of the scale was first analyzed in 2004, but it was not until 2010 that its interrater reliability, internal consistency, and prognostic or diagnostic validity supported its use for diagnosis. Additionally, although this has been only proven for traumatic etiology, the scale has demonstrated strong construct validity, with confirmed evidence of monotonicity, mutual independence, and invariant item ordering. In this regard, the hierarchy of the CRS-R has also shown a lack of invariance across relevant group factors including age, sex, etiology, enrollment facility, time since injury, and time between assessments. However, in spite that all these properties of the CRS-R contribute to reduce its diagnostic error in comparison to consensus-based tools, it is recommended that the diagnosis of DOCs is based on the clinical findings from five consecutive assessments and combined with imaging or electrophysiological-derived measures. Interestingly, some authors have proposed alternative indices and measures derived from the CRS-R, such as the CRS-R Modified Score and the CRS-R Index, pursuing an increase in the accuracy of the original version.
The total score in the CRS-R has been also identified as an important predictor of recovery of responsiveness in non-traumatic individuals with UWS in Class I studies. In the case of mixed cohorts, however, the current guidelines neither confirm nor refuse the prognostic value of the CRS-R due to insufficient evidence. However, more recent studies highlight the relevance of the information provided by the CRS-R in the prediction of the recovery of consciousness. Measures derived from the CRS-R have been also proposed to improve prognosis of DOCs. Arnaldi and colleagues introduced the CRS+, a weighted score based on the CRS-R to investigate the prognostic value of sleep patterns in the recovery of consciousness. More recently, the Consciousness Domain Index was proposed, an unsupervised machine learning clustering technique based on information from the CRS-R sub-scales to improve the prediction of recovery of consciousness.
However, although the information provided by the CRS-R might be essential to predict the clinical progress of individuals with DOCs and many attempts exist to find alternative measures that improve the predictive value of the original instrument, the heterogeneity of the data used in the different studies prevent a reliable comparison of the identified predictors and measures. Consequently, the aim of this study was to determine which information derived from the CRS-R provides the most reliable prediction of both the neurobehavioral state and recovery of consciousness at discharge of a long-term neurorehabilitation program.
- Conditions
- Disorder of Consciousness
- Being tested
- Rehabilitation program
- Keywords
- Disorders of consciousness, Unresponsive wakefulness syndrome, Minimally conscious state, Severe brain injury, Prognosis, Machine learning
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
This group of patients underwent standard rehabilitation programs set by national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Cohort undergoing rehabilitation | This group of patients underwent standard rehabilitation programs set by national guidelines. Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of consciousness
Described as Emergence from Minimal Consciousness State (MCS) or from Unresponsive Wakefulness Syndrome (UWS) (1) or presence of Disorder of Consciousness (DoC, 0)
Measured: At discharge from the rehabilitation hospital (median of 365 days)
Neurobehavioral state
Described as Minimal Consciousness State (MCS), Unresponsive Wakefulness Syndrome (UWS), or Emergence from Minimal Consciousness State (E-MCS)
Measured: At discharge from the rehabilitation hospital (median of 365 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Feb 2004
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Nisa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819177
- Sponsor's protocol ID
- CRS-R_Info
- Acronym
- CRS-R_Info
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hirschberg R, Giacino JT. The vegetative and minimally conscious states: diagnosis, prognosis and treatment. Neurol Clin. 2011 Nov;29(4):773-86. doi: 10.1016/j.ncl.2011.07.009.
PubMed 22032660Laureys S, Owen AM, Schiff ND. Brain function in coma, vegetative state, and related disorders. Lancet Neurol. 2004 Sep;3(9):537-46. doi: 10.1016/S1474-4422(04)00852-X.
PubMed 15324722Giacino 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 11839831Bruno 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 21674197Calabro RS, Naro A. Diagnosing Disorder of Consciousness: The Opening of Pandora's Box! Innov Clin Neurosci. 2016 Apr 1;13(3-4):10-1. eCollection 2016 Mar-Apr. No abstract available.
PubMed 27354922Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
PubMed 20874835'CRSR_GeneralGuidelines_20200812_v1.pdf'. Accessed: Jun. 09, 2022. [Online]. Available: https://www.sralab.org/sites/default/files/downloads/2020-09/CRSR_GeneralGuidelines_20200812_v1.pdf
J. T. Giacino, 'COMA RECOVERY SCALE-REVISED ©2004', p. 17, 2020.
Giacino 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 15605342American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.
PubMed 21112421Gerrard P, Zafonte R, Giacino JT. Coma Recovery Scale-Revised: evidentiary support for hierarchical grading of level of consciousness. Arch Phys Med Rehabil. 2014 Dec;95(12):2335-41. doi: 10.1016/j.apmr.2014.06.018. Epub 2014 Jul 7.
PubMed 25010536La Porta F, Caselli S, Ianes AB, Cameli O, Lino M, Piperno R, Sighinolfi A, Lombardi F, Tennant A. Can we scientifically and reliably measure the level of consciousness in vegetative and minimally conscious States? Rasch analysis of the coma recovery scale-revised. Arch Phys Med Rehabil. 2013 Mar;94(3):527-535.e1. doi: 10.1016/j.apmr.2012.09.035. Epub 2012 Nov 2.
PubMed 23127303Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.
PubMed 19622138Wannez 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 28543735Jox RJ, Bernat JL, Laureys S, Racine E. Disorders of consciousness: responding to requests for novel diagnostic and therapeutic interventions. Lancet Neurol. 2012 Aug;11(8):732-8. doi: 10.1016/S1474-4422(12)70154-0.
PubMed 22814543
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Information of the Coma Recovery Scale-Revised Providing the Most Reliable Prediction of the Neurobehavioral State and Recovery of Consciousness
- ClinicalTrials.gov ID
- NCT05819177
- Acronym / sponsor ID
- CRS-R_Info / CRS-R_Info
- Conditions
- Disorder of Consciousness
- Keywords
- Disorders of consciousness, Unresponsive wakefulness syndrome, Minimally conscious state, Severe brain injury, Prognosis, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Hospitales NisaUniversity, hospital or other
- Study start
- 1 Feb 2004 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Apr 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.
Background: The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument to examine the neurobehavioral condition of individuals with disorders of consciousness (DOCs). Different studies have investigated the prognostic value of the information provided by the conventional administration of the scale, while other measures derived from the scale have been proposed to improve the prognosis of DOCs. However, the heterogeneity of the data used in the different studies prevents a reliable comparison of the identified predictors and measures.
Objectives: This study investigates which information derived from the CRS-R provides the most reliable prediction of both the neurobehavioral state and recovery of consciousness at the discharge of a long-term neurorehabilitation program.
Methods: The clinical records of 171 individuals with DOCs admitted to an inpatient neurorehabilitation program for a minimum of 3 months were used to implement machine learning classifiers that were trained to predict the neurobehavioral state and recovery of consciousness at discharge.
Detailed description
Severe acquired brain injury, understood as any damage to the brain that causes coma for over 24 hours, can lead to a complex clinical condition characterized by impaired consciousness, commonly referred to as a disorder of consciousness (DOC). The concept of consciousness is multifaceted and complex and arises from the presence of both arousal, i.e. vigilance and wakefulness, and awareness, i.e. perception of the environment and self. Consequently, depending on the presence and nature of the behavioral responses to multisensory stimuli, individuals with DOC are diagnosed as either in an unresponsive wakefulness syndrome (UWS) or vegetative state (VS) if they only show reflexes, or in a minimally conscious state (MCS) if they show intentional responses. Two further subgroups have been proposed within this latter group that allow to categorize individuals in an MCS+ or in an MCS- according to the presence or absence of higher-level behaviors, respectively. Finally, individuals who show functional communication or functional use of objects are considered as emerging from the MCS.
Diagnosis of DOCs, therefore, poses a clinical challenge, as it requires the accurate analysis of behavioral signs that can be weak or inconsistent. The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument worldwide for assessing the neurobehavioral condition of individuals with DOC and features multiple cross-cultural adaptations. The CRS-R investigates the presence of 23 neurobehavioral responses, grouped in 6 different subscales, which evaluate auditory, visual, motor, oromotor, communication, and arousal functions. For each subscale, the responses are hierarchically ordered and are evaluated from higher responses (cognitively-mediated responses) to lower responses (reflexes). The diagnostic utility of the scale was first analyzed in 2004, but it was not until 2010 that its interrater reliability, internal consistency, and prognostic or diagnostic validity supported its use for diagnosis. Additionally, although this has been only proven for traumatic etiology, the scale has demonstrated strong construct validity, with confirmed evidence of monotonicity, mutual independence, and invariant item ordering. In this regard, the hierarchy of the CRS-R has also shown a lack of invariance across relevant group factors including age, sex, etiology, enrollment facility, time since injury, and time between assessments. However, in spite that all these properties of the CRS-R contribute to reduce its diagnostic error in comparison to consensus-based tools, it is recommended that the diagnosis of DOCs is based on the clinical findings from five consecutive assessments and combined with imaging or electrophysiological-derived measures. Interestingly, some authors have proposed alternative indices and measures derived from the CRS-R, such as the CRS-R Modified Score and the CRS-R Index, pursuing an increase in the accuracy of the original version.
The total score in the CRS-R has been also identified as an important predictor of recovery of responsiveness in non-traumatic individuals with UWS in Class I studies. In the case of mixed cohorts, however, the current guidelines neither confirm nor refuse the prognostic value of the CRS-R due to insufficient evidence. However, more recent studies highlight the relevance of the information provided by the CRS-R in the prediction of the recovery of consciousness. Measures derived from the CRS-R have been also proposed to improve prognosis of DOCs. Arnaldi and colleagues introduced the CRS+, a weighted score based on the CRS-R to investigate the prognostic value of sleep patterns in the recovery of consciousness. More recently, the Consciousness Domain Index was proposed, an unsupervised machine learning clustering technique based on information from the CRS-R sub-scales to improve the prediction of recovery of consciousness.
However, although the information provided by the CRS-R might be essential to predict the clinical progress of individuals with DOCs and many attempts exist to find alternative measures that improve the predictive value of the original instrument, the heterogeneity of the data used in the different studies prevent a reliable comparison of the identified predictors and measures. Consequently, the aim of this study was to determine which information derived from the CRS-R provides the most reliable prediction of both the neurobehavioral state and recovery of consciousness at discharge of a long-term neurorehabilitation program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort undergoing rehabilitation | – | Other: Rehabilitation programThis group of patients underwent standard rehabilitation programs set by national guidelines. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Disorder Of Consciousness (DOC) who had attended an inpatient neurorehabilitation program between February 2004 and December 2021 in three facilities of the same hospital network were retrospectively extracted from their medical records.
Key inclusion criteria (1 listed)
- diagnosis with (Unresponsive Wakefulness Syndrome) UWS or Minimal Consciousness State (MCS) due to either a vascular, anoxic or traumatic origin
Key exclusion criteria (1 listed)
- individuals who did not attended the program for at least three months
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 |
|---|---|---|
| Rehabilitation programThis group of patients underwent standard rehabilitation programs set by national guidelines. | Other | Cohort undergoing rehabilitation |
Primary outcome
Recovery of consciousness
Time frame: At discharge from the rehabilitation hospital (median of 365 days)
Described as Emergence from Minimal Consciousness State (MCS) or from Unresponsive Wakefulness Syndrome (UWS) (1) or presence of Disorder of Consciousness (DoC, 0)
Neurobehavioral state
Time frame: At discharge from the rehabilitation hospital (median of 365 days)
Described as Minimal Consciousness State (MCS), Unresponsive Wakefulness Syndrome (UWS), or Emergence from Minimal Consciousness State (E-MCS)
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 19 Apr 2023.
- Background: PubMed 22032660Hirschberg R, Giacino JT. The vegetative and minimally conscious states: diagnosis, prognosis and treatment. Neurol Clin. 2011 Nov;29(4):773-86. doi: 10.1016/j.ncl.2011.07.009.
- Background: PubMed 15324722Laureys S, Owen AM, Schiff ND. Brain function in coma, vegetative state, and related disorders. Lancet Neurol. 2004 Sep;3(9):537-46. doi: 10.1016/S1474-4422(04)00852-X.
- 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 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 27354922Calabro RS, Naro A. Diagnosing Disorder of Consciousness: The Opening of Pandora's Box! Innov Clin Neurosci. 2016 Apr 1;13(3-4):10-1. eCollection 2016 Mar-Apr. No abstract available.
- Background: PubMed 20874835Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
- Background'CRSR_GeneralGuidelines_20200812_v1.pdf'. Accessed: Jun. 09, 2022. [Online]. Available: https://www.sralab.org/sites/default/files/downloads/2020-09/CRSR_GeneralGuidelines_20200812_v1.pdf
- BackgroundJ. T. Giacino, 'COMA RECOVERY SCALE-REVISED ©2004', p. 17, 2020.
- 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 21112421American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.
- Background: PubMed 25010536Gerrard P, Zafonte R, Giacino JT. Coma Recovery Scale-Revised: evidentiary support for hierarchical grading of level of consciousness. Arch Phys Med Rehabil. 2014 Dec;95(12):2335-41. doi: 10.1016/j.apmr.2014.06.018. Epub 2014 Jul 7.
- Background: PubMed 23127303La Porta F, Caselli S, Ianes AB, Cameli O, Lino M, Piperno R, Sighinolfi A, Lombardi F, Tennant A. Can we scientifically and reliably measure the level of consciousness in vegetative and minimally conscious States? Rasch analysis of the coma recovery scale-revised. Arch Phys Med Rehabil. 2013 Mar;94(3):527-535.e1. doi: 10.1016/j.apmr.2012.09.035. Epub 2012 Nov 2.
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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 1 inclusion and 1 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 19 Apr 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?
Recovery of consciousness (time frame: At discharge from the rehabilitation hospital (median of 365 days)). The study lists 2 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 NCT05819177, which also lists 26 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 19 Apr 2023.