Clinical trial NCT03732092: The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
Official title: The Effects of Olfactory Stimulation on Diagnosis and Prognosis of Patients With Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Conscious State
Vegetative State
Keywords: disorders of consciousness
prognosis prediction
minimally conscious state
vegetative state
olfactory stimulation
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with disorders of consciousness

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Coma Recovery Scale-Revised （CRS-R）
timeFrame: six months later
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
name: Patients with disorders of consciousness were assessed by Coma Di, Pro
role: STUDY_CHAIR
References:
citation: Chiaravalloti A, Pagani M, Micarelli A, Di Pietro B, Genovesi G, Alessandrini M, Schillaci O. Cortical activity during olfactory stimulation in multiple chemical sensitivity: a (18)F-FDG PET/CT study. Eur J Nucl Med Mol Imaging. 2015 Apr;42(5):733-40. doi: 10.1007/s00259-014-2969-2. Epub 2015 Feb 18.
citation: Wang J, Zhang S, Liu W, Zhang Y, Hu Z, Sun Z, Di H. Olfactory Stimulation and the Diagnosis of Patients With Disorders of Consciousness: A Double-Blind, Randomized Clinical Trial. Front Neurosci. 2022 Feb 17;16:712891. doi: 10.3389/fnins.2022.712891. eCollection 2022.