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CompletedNCT03508336Updated Apr 25, 2018

The Initiation of Swallowing Can Indicate the Prognosis of DOC

An observational study in Minimally Conscious State and Vegetative State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 27 Years to 77 Years. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Hangzhou Normal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
27 Years to 77 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Minimally Conscious State
  • Vegetative State

Keywords

  • disorders of consciousness
  • swallowing
  • prognosis prediction
  • minimally conscious state
  • vegetative state
03

Who can participate

Ages eligible
27 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with disorders of consciousness

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testComa Recovery Scale-Revised

    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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: Six month later

06

Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
07

References and documents

Publications

  • Giacino JT, Schnakers C, Rodriguez-Moreno D, Kalmar K, Schiff N, Hirsch J. Behavioral assessment in patients with disorders of consciousness: gold standard or fool's gold? Prog Brain Res. 2009;177:33-48. doi: 10.1016/S0079-6123(09)17704-X. PubMed 19818893 ↗
  • Hansen TS, Engberg AW, Larsen K. Functional oral intake and time to reach unrestricted dieting for patients with traumatic brain injury. Arch Phys Med Rehabil. 2008 Aug;89(8):1556-62. doi: 10.1016/j.apmr.2007.11.063. PubMed 18674990 ↗
  • Wang J, Wang J, Hu X, Xu L, Tian J, Li J, Fang D, Huang W, Sun Y, He M, Laureys S, Di H. The Initiation of Swallowing Can Indicate the Prognosis of Disorders of Consciousness: A Self-Controlled Study. Front Neurol. 2019 Nov 14;10:1184. doi: 10.3389/fneur.2019.01184. eCollection 2019. PubMed 31798516 ↗

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT03508336
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Dr, Hangzhou Normal University) — Principal investigator
First posted
Apr 25, 2018
Start date
Jun 3, 2016
Primary completion
Mar 24, 2018
Completion
Apr 12, 2018
Last update
Apr 25, 2018

Study contacts

Haibo Di, Pro
study chair · International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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