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CompletedNCT03732092Updated Dec 29, 2020

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

An observational study in Minimally Conscious State and Vegetative State, sponsored by Jing Wang. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-29.

Sponsored by Jing Wang · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Minimally Conscious State
  • Vegetative State

Keywords

  • disorders of consciousness
  • prognosis prediction
  • minimally conscious state
  • vegetative state
  • olfactory stimulation
03

In context

Persistent Vegetative State

88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 31 observational studies indexed under Persistent Vegetative State.

Browse Persistent Vegetative State studies →

Lead sponsor

Jing Wang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with disorders of consciousness

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • history of forehead injury;
  • nasal fractures;
  • tracheotomy;
  • developmental mental or neurological diseases leading to recorded dysfunction;
  • severe fractures of the extremities.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Coma Recovery Scale-Revised

Interventions

  • Diagnostic testComa Recovery Scale-Revised

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: six months later

07

Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
08

References and documents

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. PubMed 25690545 ↗
  • 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. PubMed 35250440 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2018, 8 months.

Of 16 observational studies under Persistent Vegetative State, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2018
First posted
Nov 6, 2018
StartActual
Mar 15, 2018
Primary completionActual
Nov 15, 2018
CompletionActual
Dec 15, 2019
Last update
Dec 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03732092
Lead sponsor
Jing Wang
Responsible party
Jing Wang (Principal Investigator, Hangzhou Normal University) — Sponsor-investigator
First posted
Nov 6, 2018
Start date
Mar 15, 2018
Primary completion
Nov 15, 2018
Completion
Dec 15, 2019
Last update
Dec 29, 2020

Study contacts

Patients with disorders of consciousness were assessed by Coma Di, Pro
study chair · International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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