The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients

Study Overview
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Brief Summary
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Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).

Detailed Description
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Previous studies suggested that olfactory stimulus have some effect on some patients with disorders of consciousness. Then, the aim of the present study is to know the prognostic value of olfactory stimulation and the diagnosis for DOC patients. DOC patients were recruited (standard diagnosis procedure is 5 times CRS-R testing within 10 days). The different stimuli were as follows: 1) 1-octene-3-ol, odor. 2) pyridine, odor. 3) water. We presented these stimuli randomly, and we recorded the patient's CRS-R scale behavioral response and response to olfactory stimulation. Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).

Official Title
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The Effects of Olfactory Stimulation on Diagnosis and Prognosis of Patients With Disorders of Consciousness

Conditions
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Minimally Conscious State, Vegetative State

Intervention / Treatment
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* Diagnostic Test: Coma Recovery Scale-Revised


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old; non-acute phase; after coma; no nerve stimulation drugs within 48 hours before the implementation of the study; no neuromuscular blockers within 24 hours before implementation Exclusion Criteria: history of forehead injury; nasal fractures; tracheotomy; developmental mental or neurological diseases leading to recorded dysfunction; severe fractures of the extremities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with disorders of consciousness<br>Patients with disorders of consciousness from several brain injury, assessed by Coma Recovery Scale-Revised (CRS-R), have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state. | Diagnostic Test: Coma Recovery Scale-Revised<br>* Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected three stimuli: 1) 1-octene-3-ol, 2) pyridine, 3) water. We presented these three stimuli in front of the patients nose for 3 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coma Recovery Scale-Revised （CRS-R） | The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The higher items represent conscious related behaviour while the lower items for each sub-scale represent reflexive activity. Basis for scoring was the presence or absence of the specific behaviour in response to standard stimuli. Patients were followed up for 1, 3, and 6 months to track the prognosis of patients by CRS-R. | six months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disorders of consciousness, prognosis prediction, minimally conscious state, vegetative state, olfactory stimulation