- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508336
The Initiation of Swallowing Can Indicate the Prognosis of DOC
April 16, 2018 updated by: Jing Wang, Hangzhou Normal University
The Initiation of Swallowing Can Indicate the Prognosis of Disorders of Consciousness
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 3100036
- International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with disorders of consciousness
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coma Recovery Scale-Revised (CRS-R)
Time Frame: Six month later
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examine the prognostic value of patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R 6-month later
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Six month later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Haibo Di, Pro, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2016
Primary Completion (Actual)
March 24, 2018
Study Completion (Actual)
April 12, 2018
Study Registration Dates
First Submitted
April 16, 2018
First Submitted That Met QC Criteria
April 16, 2018
First Posted (Actual)
April 25, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017A02529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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