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

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732092
• Other study ID #: 2018A04355
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2020
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

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.

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jing Wang

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months later