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

Completed

• Conditions: Minimally Conscious State; Vegetative State
• Interventions: Diagnostic Test: Coma Recovery Scale-Revised

• Registration Number: NCT03732092
• Lead Sponsor: Jing Wang

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).

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-04
• Study First Posted: 2018-11-06
• Primary Completion: 2018-11-15
• Study Completion: 2019-12-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with disorders of consciousness	Coma Recovery Scale-Revised	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China