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

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

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

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.
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.

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
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

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.

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

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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