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CompletedNCT02988206Updated Dec 14, 2016

Personalized Objects Can Improve the Diagnosis of EMCS From MCS

An interventional study of Personalized Objects and non-personalized Objects in Patients in Minimally Conscious State, sponsored by Hangzhou Normal University. Completed. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Patients in Minimally Conscious State
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In context

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Other
    Personalized Objects

    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..

    Behavioral: Personalized Objects · Behavioral: non-personalized Objects

  • Other
    non-personalized objects

    The item "Functional Object Use" was assessed by using non-personalized objects

    Behavioral: non-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

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What researchers measure

Primary outcomes

  1. The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer

    Time frame: one week

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Sun Y, Wang J, Heine L, Huang W, Wang J, Hu N, Hu X, Fang X, Huang S, Laureys S, Di H. Personalized objects can optimize the diagnosis of EMCS in the assessment of functional object use in the CRS-R: a double blind, randomized clinical trial. BMC Neurol. 2018 Apr 12;18(1):38. doi: 10.1186/s12883-018-1040-5. PubMed 29649978 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02988206
Lead sponsor
Hangzhou Normal University
Responsible party
Yuxiao Sun (Undergraduate student, Hangzhou Normal University) — Principal investigator
First posted
Dec 9, 2016
Start date
Mar 2015
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Dec 14, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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