Clinical trial NCT03508336: The Initiation of Swallowing Can Indicate the Prognosis of DOC
Official title: The Initiation of Swallowing Can Indicate the Prognosis of Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Conscious State
Vegetative State
Keywords: disorders of consciousness
swallowing
prognosis prediction
minimally conscious state
vegetative state
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 24
Sex: ALL
Minimum age (years): 27
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with disorders of consciousness

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coma Recovery Scale-Revised （CRS-R）
timeFrame: Six month later
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
name: Haibo Di, Pro
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.