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

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).

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Key information

Conditions

Minimally Conscious State Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness Vegetative State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coma Recovery Scale-Revised

Diagnostic Test

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.

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.

Sponsors and collaborators

Lead sponsor

Jing Wang

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Nov 6, 2018
Registry last updated: Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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