The Initiation of Swallowing Can Indicate the Prognosis of DOC

NCT03508336 | Completed DMC

• 1 other identifier: 2017A02529
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimally Conscious State; Vegetative State

Keywords

disorders of consciousness; swallowing; prognosis prediction; minimally conscious state; vegetative state

Outcome Measures

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

  Six month later

Study Arms (1)

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

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.

patients with disorders of consciousness

Eligibility Criteria

• Age: 27 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with disorders of consciousness

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Haibo Di, Pro

  International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: June 3, 2016
• Primary Completion: March 24, 2018
• Study Completion: April 12, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)