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

NCT05954650 | Completed

• 1 other identifier: P0428112022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Disorder of Consciousness

Keywords

Disorders of Consciousness; Minimally Conscious State; Minimally Conscious State Plus; Minimally Conscious State Minus; Disability Rating Scale; Functional Independence

Outcome Measures

Primary Outcomes (9)

• Baseline clinical state

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

Patients in a Minimally Conscious State

Patients diagnosed as in a Minimally Conscious State "Plus" and "Minus"

Behavioral: Rehabilitation

Interventions

Rehabilitation BEHAVIORAL

Physical therapy and multisensory stimulation adjusted to the needs of each patient.

Patients in a Minimally Conscious State

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of UWS
• Being younger than 18 years
• DOC persisting more than 6 months
• Absence of follow-up

Sponsors & Collaborators

• Hospitales Nisa: lead
• Generalitat Valenciana: collaborator

Study Sites (2)

Hospitales NISA

Valencia, 46011, Spain

Location

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, 46011, Spain

Location

Related Publications (16)

• 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.

  PMID: 31886461 BACKGROUND

• Bruno 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.

  PMID: 21674197 BACKGROUND

• Bruno 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.

  PMID: 22081100 BACKGROUND

• Colantonio 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.

  PMID: 21347507 BACKGROUND

• Katz 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.

  PMID: 19818896 BACKGROUND

• Giacino 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.

  PMID: 11839831 BACKGROUND

• 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.

  PMID: 15605342 BACKGROUND

• Golden 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.

  PMID: 35398046 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Pape 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.

  PMID: 16809207 BACKGROUND

• Rappaport 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.

  PMID: 7073452 BACKGROUND

• Song 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.

  PMID: 32306061 BACKGROUND

• Stineman 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.

  PMID: 12589617 BACKGROUND

• Thibaut 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.

  PMID: 31773246 BACKGROUND

• Wannez 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.

  PMID: 28543735 BACKGROUND

• Kondziella D, Bender A, Diserens K, van Erp W, Estraneo A, Formisano R, Laureys S, Naccache L, Ozturk S, Rohaut B, Sitt JD, Stender J, Tiainen M, Rossetti AO, Gosseries O, Chatelle C; EAN Panel on Coma, Disorders of Consciousness. European Academy of Neurology guideline on the diagnosis of coma and other disorders of consciousness. Eur J Neurol. 2020 May;27(5):741-756. doi: 10.1111/ene.14151. Epub 2020 Feb 23.

  PMID: 32090418 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 20, 2023
• Study Start: September 30, 2004
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

ES (2)