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Completed

NCT Number: NCT03508336

The Initiation of Swallowing Can Indicate the Prognosis of DOC

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.

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Key information

Age range

27 year–77 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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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 four stimuli: 1) only a command (as recommended in CRS-R), which was "open your mouth"; 2) only a spoon without a command; 3) a spoon and a command, the command was "there is a spoon and open your mouth"; 4) a spoon with water and a command, the command was "there is a spoon with water and open your mouth". In brief, 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.

Primary outcomes

  1. Coma Recovery Scale-Revised (CRS-R)

    Time frame: Six month later

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

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

The Initiation of Swallowing Can Indicate the Prognosis of Disorders of Consciousness

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Apr 25, 2018

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

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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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