Patients in Minimally Conscious StateNCT02988206
Personalized Objects Can Improve the Diagnosis of EMCS From MCS
A study testing Personalized Objects and non-personalized Objects in people with Patients in Minimally Conscious State, run by Hangzhou Normal University.
Trial summary
In this study，researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS). Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Patients in Minimally Conscious State
- What is being tested?
- Personalized Objects and non-personalized Objects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients in minimally conscious state;
- patients with stable condition;
- each patient has athletic ability to some extent.
Who cannot join
- premorbid neurology antecedent;
- patients in coma or vegetative state;
- patients < 1 months after the acute brain injury.
About this study
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.
- Conditions
- Patients in Minimally Conscious State
- Being tested
- Personalized Objects, non-personalized Objects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ObjectsBehavioural
personalized objects are based on the observation or the reports from family
non-personalized ObjectsBehavioural
non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
| Study group | Role | What they receive |
|---|---|---|
| Personalized Objects | Other | 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.. Receives: Behavioral: Personalized Objects; Behavioral: non-personalized Objects |
| non-personalized objects | Other | The item "Functional Object Use" was assessed by using non-personalized objects Receives: Behavioral: non-personalized Objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients in Minimally Conscious StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxiao Sun, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988206
- Sponsor's protocol ID
- 2016R423055
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Objects Can Improve the Diagnosis of EMCS From MCS
- ClinicalTrials.gov ID
- NCT02988206
- Acronym / sponsor ID
- 2016R423055
- Conditions
- Patients in Minimally Conscious State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Objects | Other | Behavioral: Personalized Objects, Behavioral: non-personalized ObjectsThe item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.. |
| non-personalized objects | Other | Behavioral: non-personalized ObjectsThe item "Functional Object Use" was assessed by using non-personalized objects |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients in minimally conscious state;
- patients with stable condition;
- each patient has athletic ability to some extent.
Key exclusion criteria (3 listed)
- premorbid neurology antecedent;
- patients in coma or vegetative state;
- patients < 1 months after the acute brain injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Objectspersonalized objects are based on the observation or the reports from family | Behavioural | Personalized Objects |
| non-personalized Objectsnon-personalized objects are based on the suggestion in CRS-R,which are comb and cup | Behavioural | Personalized Objects, non-personalized objects |
Primary outcome
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 29649978Sun 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.
- Individual participant dataSharing planned: No
Related trials for Patients in Minimally Conscious State
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
Not yet recruiting
Temporal Interference Stimulation for Disorders of Consciousness
Disorder of Consciousness, Minimally Conscious State
Not yet recruiting
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Disorders of Consciousness, Vegetative State
Enrolling by invitation
Prognostication of Recovery in Early Disorders of Consciousness Study
Disorder of Consciousness, Comatose
Not yet recruitingObservational study
Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)
Consciousness Disorders, Persistent Vegetative State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Objects and non-personalized Objects in people with Patients in Minimally Conscious State, run by Hangzhou Normal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.