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

NCT03732092 | Completed DMC

• 1 other identifier: 2018A04355
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Minimally Conscious State; Vegetative State

Keywords

disorders of consciousness; prognosis prediction; minimally conscious state; vegetative state; olfactory stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

patients with disorders of consciousness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with disorders of consciousness

You may qualify if:

• 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

You may not qualify if:

• history of forehead injury;
• nasal fractures;
• tracheotomy;
• developmental mental or neurological diseases leading to recorded dysfunction;
• severe fractures of the extremities.

Sponsors & Collaborators

• Jing Wang: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (2)

• 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: 10.1007/s00259-014-2969-2. Epub 2015 Feb 18.

  PMID: 25690545 RESULT

• Wang J, Zhang S, Liu W, Zhang Y, Hu Z, Sun Z, Di H. Olfactory Stimulation and the Diagnosis of Patients With Disorders of Consciousness: A Double-Blind, Randomized Clinical Trial. Front Neurosci. 2022 Feb 17;16:712891. doi: 10.3389/fnins.2022.712891. eCollection 2022.

  PMID: 35250440 DERIVED

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Patients with disorders of consciousness were assessed by Coma Di, Pro

  International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: March 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: December 15, 2019
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)