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

Sponsor

Jing Wang (Other)

Overall Status

Completed

CT.gov ID

NCT03732092

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Minimally Conscious State Vegetative State	Diagnostic Test: Coma Recovery Scale-Revised

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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Actual Primary Completion Date :

Nov 15, 2018

Actual Study Completion Date :

Dec 15, 2019

Arms and Interventions

Arm	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.	Diagnostic Test: Coma 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.

Arm

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.

Diagnostic Test: Coma 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.

Outcome Measures

Primary Outcome Measures

Coma Recovery Scale-Revised （CRS-R） [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang	China	3100036

Sponsors and Collaborators

Jing Wang

Investigators

Study Chair: Patients with disorders of consciousness were assessed by Coma Di, Pro, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University