The Initiation of Swallowing Can Indicate the Prognosis of DOC

Completed

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

• Registration Number: NCT03508336
• Lead Sponsor: Hangzhou Normal University

Brief Summary

This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients.

Detailed Description

Studies suggest that the initiation and patterning of swallowing of the pharyngeal phase is also under active cortical control for both spontaneous as well as volitional swallowing in awake humans and non-human primates. A recent study found that most patients of disorders of consciousness (DOC) would recover their swallowing ability quickly. And there is no study about detecting the initiation of swallowing act in DOC patients. This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients. DOC patients were recruited (standard diagnosis procedure is 4 times CRS-R testing within 2 weeks). The different four stimuli were as follows: 1) One command (as recommended in CRS-R) which was "open your mouth". 2) Put a spoon in front of the patient's mouth without a command. 3) One command with a spoon in front of the mouth, the command is "there is a spoon and open your mouth". 4) One command with a spoon full of water in front of the mouth, the command is "there is a spoon with water and open your mouth". We presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals.

Study Timeline

• Study Start: 2016-06-03
• Primary Completion: 2018-03-24
• Status Verified: 2018-04
• Study Completion: 2018-04-12
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• age ≥ 18 years
• no administration of central nervous system stimulant, neuro-muscular blocking agents, or sedative within the prior 24 hours
• a diagnosis of VS or MCS-, based on the behavioral assessment of standardized CRS-R
• periods of eye opening (indicating preserved sleep-wake cycles).

Exclusion Criteria

• documented history of prior brain injury
• premorbid illness resulting in documented functional disabilities up to time of the injury
• acute illness (e.g., pyrexia, pneumonia, diarrhea)
• receiving hyperbaric oxygen treatments within 2 hours
• fracture of the mandible.

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 month later	examine the prognostic value of patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R 6-month later

Trial Locations

Locations (1)

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