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Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02988206
Enrollment
21
Registered
2016-12-09
Start date
2015-03-31
Completion date
2016-08-31
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in Minimally Conscious State

Brief summary

In this study,researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).

Detailed description

The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own name and face, are more effective to elicit the patient's response than that of non-self-referential stimuli. The item Functional Object Use was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.The rest assessments were performed following the standard protocol of CRS-R. The differences between functional use of the two types of objects was analyzed by Chi-square test. Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the using of personalized objects.

Interventions

BEHAVIORALPersonalized Objects

personalized objects are based on the observation or the reports from family

BEHAVIORALnon-personalized Objects

non-personalized objects are based on the suggestion in CRS-R,which are comb and cup

Sponsors

Hangzhou Normal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* patients in minimally conscious state; * patients with stable condition; * each patient has athletic ability to some extent.

Exclusion criteria

* premorbid neurology antecedent; * patients in coma or vegetative state; * patients \< 1 months after the acute brain injury.

Design outcomes

Primary

MeasureTime frame
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they preferone week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026