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The Initiation of Swallowing Can Indicate the Prognosis of DOC

NCT03508336 — Completed, 24 participants, Hangzhou Normal University

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

RegistryNCT03508336
StatusCompleted
Study typeObservational
Enrollment24 (Actual)
SponsorHangzhou Normal University (Other)
ConditionsMinimally Conscious State, Vegetative State
InterventionsComa Recovery Scale-Revised (Diagnostic test)
Datesstart 2016-06-03, primary completion 2018-03-24, completion 2018-04-12, first posted 2018-04-25, last updated 2018-04-25
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
patients with disorders of consciousnessDiagnostic Test: Coma Recovery Scale-RevisedPatients 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.
  • 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.

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 27 Years to 77 Years

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.

+Locations (1)

FacilityCityCountryStatus
International Vegetative State and Consciousness Science Institute, Hangzhou Normal UniversityHangzhou, ZhejiangChina

+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. PMID 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. PMID 18674990
  • Results publication: 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. PMID 31798516

+Investigators

  • Haibo Di, Pro, Study chair, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

My Notes