The Initiation of Swallowing Can Indicate the Prognosis of DOC

NCT ID: NCT03508336

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-03
• Study Completion Date: 2018-04-12

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.

Conditions

Minimally Conscious State; Vegetative State

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Coma Recovery Scale-Revised

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Jing Wang

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haibo Di, Pro

Role: STUDY_CHAIR

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Locations

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 19818893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18674990 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31798516 (View on PubMed)

Other Identifiers

2017A02529

Identifier Type: -

Identifier Source: org_study_id