Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Hangzhou Normal University

Status: Completed

Conditions: Patients in Minimally Conscious State

Treatments: Behavioral: non-personalized Objects; Behavioral: Personalized Objects

Study type: Interventional

Funder types: Other

Identifiers

NCT02988206

2016R423055

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

21 participants in 2 patient groups

Personalized Objects

Other group

Description:

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..

Treatment:

Behavioral: Personalized Objects

Behavioral: non-personalized Objects

non-personalized objects

Other group

Description:

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

Treatment:

Behavioral: non-personalized Objects