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Clinical Trials/NCT03732092
NCT03732092
Completed
Not Applicable

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

Jing Wang1 site in 1 country20 target enrollmentMarch 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Minimally Conscious State
Sponsor
Jing Wang
Enrollment
20
Locations
1
Primary Endpoint
Coma Recovery Scale-Revised (CRS-R)
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 15, 2018
End Date
December 15, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jing Wang
Responsible Party
Sponsor Investigator
Principal Investigator

Jing Wang

Principal Investigator

Hangzhou Normal University

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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