The Initiation of Swallowing Can Indicate the Prognosis of DOC

H

Hangzhou Normal University

Status

Completed

Conditions

Vegetative State
Minimally Conscious State

Treatments

Diagnostic Test: Coma Recovery Scale-Revised

Study type

Observational

Funder types

Other

Identifiers

NCT03508336
2017A02529

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

27 to 77 years old

Volunteers

No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

patients with disorders of consciousness
Description:
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.
Treatment:
Diagnostic Test: Coma Recovery Scale-Revised

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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