StrokeNCT02081040
Coughing in Infratentorial Brain Lesion Patients
An observational study of Stroke, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Not applicable (observational study with no active intervention)
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dysphagia patients due to brain lesions at a university affiliated hospital
Who may be able to join
- Group 1- Brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 2- Non-brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 3- Stroke patients with no evidence of dysphagia
Who cannot join
- Episode of acute pneumonia or pulmonary embolism at time of enrollment
- Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury)
- Stroke patients with multiple brain lesions
- Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
- Previous episode of abdominal or thoracic surgery within one year of enrollment
- Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles.
Show all 10Show fewer
- Episode of rib fracture within one year of enrollment
- Chronic alcoholism
- Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation
- Patient with tracheostomy state
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bucheon St Mary's Hospital
Bucheon-si, Gyonngido, 420-717
About this study
Official title: Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography
To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department.
Read the detailed description
Our previous work has shown that stroke patients with dysphagia have impaired diaphragm excursion in comparison to those with no dysphagia. It has been postulated that respiratory and cough function are primarily controlled by respiratory and swallowing centers located in the brainstem.We postulated that those with infratentorial brain lesions would have more impaired cough and respiratory function than those with non-brainstem lesions and supratentorial brain lesions.
However there has been no studies whether those with infratentorial brain lesions have more impaired cough function and decreased diaphragm excursion than those with supratentorial brain lesions.
- Conditions
- Stroke
- Being tested
- Not applicable (observational study with no active intervention)
- Keywords
- brainstem, diaphragm, deglutition disorder, sonography
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (observational study with no active intervention)Other
| Study group | Role | What they receive |
|---|---|---|
| Infratentorial dysphagia patients | Infratentorial brain lesion patients with confirmed evidence of dysphagia | |
| Supratentorial dysphagia patients | Supratentorial brain lesions\ patients with confirmed evidence of dysphagia | |
| Brain lesion patients without dysphagia | Brain lesion patients with no evidence of dysphagia Receives: Other: Not applicable (observational study with no active intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm excursion
Diaphragm excursion as assessed by m mode sonography
Measured: baseline one time
Secondary outcomes (2)
Maximal inspiratory pressure
Measured: baseline one time
Peak cough flow force during voluntary coughing
Measured: baseline one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, MD PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081040
- Sponsor's protocol ID
- HC 13OISE0066_1
- Status last verified
- Feb 2015
- First submitted
- 4 Mar 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography
- ClinicalTrials.gov ID
- NCT02081040
- Acronym / sponsor ID
- HC 13OISE0066_1
- Conditions
- Stroke
- Keywords
- brainstem, diaphragm, deglutition disorder, sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department.
Detailed description
Our previous work has shown that stroke patients with dysphagia have impaired diaphragm excursion in comparison to those with no dysphagia. It has been postulated that respiratory and cough function are primarily controlled by respiratory and swallowing centers located in the brainstem.We postulated that those with infratentorial brain lesions would have more impaired cough and respiratory function than those with non-brainstem lesions and supratentorial brain lesions.
However there has been no studies whether those with infratentorial brain lesions have more impaired cough function and decreased diaphragm excursion than those with supratentorial brain lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infratentorial dysphagia patients | – | –Infratentorial brain lesion patients with confirmed evidence of dysphagia |
| Supratentorial dysphagia patients | – | –Supratentorial brain lesions\ patients with confirmed evidence of dysphagia |
| Brain lesion patients without dysphagia | – | Other: Not applicable (observational study with no active intervention)Brain lesion patients with no evidence of dysphagia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dysphagia patients due to brain lesions at a university affiliated hospital
Key inclusion criteria (1 listed)
- Group 1- Brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 2- Non-brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 3- Stroke patients with no evidence of dysphagia
Key exclusion criteria (10 listed)
- Episode of acute pneumonia or pulmonary embolism at time of enrollment
- Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury)
- Stroke patients with multiple brain lesions
- Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
- Previous episode of abdominal or thoracic surgery within one year of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable (observational study with no active intervention) | Other | Brain lesion patients without dysphagia |
Primary outcome
Diaphragm excursion
Time frame: baseline one time
Diaphragm excursion as assessed by m mode sonography
2 secondary outcomes
Maximal inspiratory pressure
Time frame: baseline one time
Peak cough flow force during voluntary coughing
Time frame: baseline one time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Im, MD PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm excursion (time frame: baseline one time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.