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OpenTrials
Completed

NCT Number: NCT02988206

Personalized Objects Can Improve the Diagnosis of EMCS From MCS

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

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Key information

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized Objects

Behavioral

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

non-personalized Objects

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2016
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.