- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03732092
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients
December 24, 2020 updated by: Jing Wang
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of Patients With Disorders of Consciousness
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 3100036
- International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with disorders of consciousness
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with disorders of consciousness
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coma Recovery Scale-Revised (CRS-R)
Time Frame: six months later
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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.
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six months later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Patients with disorders of consciousness were assessed by Coma Di, Pro, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
November 15, 2018
Study Completion (Actual)
December 15, 2019
Study Registration Dates
First Submitted
November 4, 2018
First Submitted That Met QC Criteria
November 4, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
December 29, 2020
Last Update Submitted That Met QC Criteria
December 24, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018A04355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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