The Initiation of Swallowing Can Indicate the Prognosis of DOC

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508336
• Other study ID #: 2017A02529
• Status: Completed
• First received: April 16, 2018
• Last updated: April 16, 2018
• Start date: June 3, 2016
• Est. completion date: April 12, 2018

Study information

• Verified date: April 2018
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 12, 2018
• Est. primary completion date: March 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

Diagnostic Test:
• Coma 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.

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six month later