Stroke, AcuteNCT05603377
Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients
A study testing functional endoscopic evaluation of swallow in people with Stroke, Acute, run by Sohag University at 1 site in Egypt.
Trial summary
Stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). Dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- functional endoscopic evaluation of swallow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients> (18 years). Conscious patients Stroke patients confirmed by brain imaging Stroke in the acute and sub-acute phase
Who cannot join
- Previous stroke Non stroke dysphagia History of other neurologic disorders other than cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
ahmed M Emam, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
Stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). Dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. It is reported that the occurrence rate of post-stroke dysphagia (PSD) is varies widely, ranging from 19% to 81%, the reason may be associated with the type of stroke, the assessment tools, the timing of the assessment, and so on .Dysphagia is associated with pneumonia, malnutrition, dehydration, increased mortality, and poor long-term outcome. It has been shown that early detection of dysphagia allows for immediate intervention and thereby reduces morbidity, duration of hospitalization, and overall health care costs. Oropharyngeal dysphagia (OD) can have a high impact on the general health of affected patients and can produce two main types of complications in patients with post stroke: (1) those caused by impaired efficacy of swallow, present in 25%-75% of patients, which leads to malnutrition and dehydration and (2) impaired safety of swallow which leads to tracheobronchial aspiration that may cause pneumonia in 50% of cases. Both OD and aspiration are highly prevalent conditions in patients with stroke . Dysphagia is more common in hemorrhagic stroke compared with ischemic stroke, so far, most studies have focused on the latter, presumably due to its higher incidence .The recognition of a brain lesion pattern associated with oropharyngeal dysphagia could help to distinguish those patients in need of more in-depth evaluation and the subsequent adoption of preventive measures. However, it is difficult to predict which patients are susceptible to developing swallowing alterations depending on neuroimaging findings. However, the findings have been inconsistent, mainly due to simplification in the classification of brain injuries into a small number of groups, or to the different methods employed in assessing swallowing function
- Conditions
- Stroke, Acute
- Being tested
- functional endoscopic evaluation of swallow
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional endoscopic evaluation of swallowDiagnostic test
functional endoscopic evaluation of swallow
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Not described Receives: Diagnostic Test: functional endoscopic evaluation of swallow |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral phase of swallow
if there is residue in oral phase of swallow with fluids ,semisolids ,solids
Measured: within 7 days
pharyngeal phase of swallow
if there is residue or penetration or aspiration post swallow with fluids ,semisolids, solids
Measured: within 7 days
brain imaging computed tomography CT or magnetic resonance imaging MRI
brain imaging computed tomography CT or magnetic resonance imaging MRI correlation with oral phase and pharyngeal phase of swallow
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azhar Elsayed Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603377
- Sponsor's protocol ID
- Soh-Med-22-10-18
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abd-Allah F, Khedr E, Oraby MI, Bedair AS, Georgy SS, Moustafa RR. Stroke burden in Egypt: data from five epidemiological studies. Int J Neurosci. 2018 Aug;128(8):765-771. doi: 10.1080/00207454.2017.1420068. Epub 2018 Jan 4.
PubMed 29258372Hess F, Foerch C, Keil F, Seiler A, Lapa S. Association of Lesion Pattern and Dysphagia in Acute Intracerebral Hemorrhage. Stroke. 2021 Aug;52(9):2921-2929. doi: 10.1161/STROKEAHA.120.032615. Epub 2021 May 18.
PubMed 34000833Meng PP, Zhang SC, Han C, Wang Q, Bai GT, Yue SW. The Occurrence Rate of Swallowing Disorders After Stroke Patients in Asia: A PRISMA-Compliant Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105113. doi: 10.1016/j.jstrokecerebrovasdis.2020.105113. Epub 2020 Jul 9.
PubMed 32912517Wilmskoetter J, Bonilha L, Martin-Harris B, Elm JJ, Horn J, Bonilha HS. Mapping acute lesion locations to physiological swallow impairments after stroke. Neuroimage Clin. 2019;22:101685. doi: 10.1016/j.nicl.2019.101685. Epub 2019 Jan 22.
PubMed 30711683
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients
- ClinicalTrials.gov ID
- NCT05603377
- Acronym / sponsor ID
- Soh-Med-22-10-18
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- 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.
Stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). Dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. It is reported that the occurrence rate of post-stroke dysphagia (PSD) is varies widely, ranging from 19% to 81%, the reason may be associated with the type of stroke, the assessment tools, the timing of the assessment, and so on .Dysphagia is associated with pneumonia, malnutrition, dehydration, increased mortality, and poor long-term outcome. It has been shown that early detection of dysphagia allows for immediate intervention and thereby reduces morbidity, duration of hospitalization, and overall health care costs. Oropharyngeal dysphagia (OD) can have a high impact on the general health of affected patients and can produce two main types of complications in patients with post stroke: (1) those caused by impaired efficacy of swallow, present in 25%-75% of patients, which leads to malnutrition and dehydration and (2) impaired safety of swallow which leads to tracheobronchial aspiration that may cause pneumonia in 50% of cases. Both OD and aspiration are highly prevalent conditions in patients with stroke . Dysphagia is more common in hemorrhagic stroke compared with ischemic stroke, so far, most studies have focused on the latter, presumably due to its higher incidence .The recognition of a brain lesion pattern associated with oropharyngeal dysphagia could help to distinguish those patients in need of more in-depth evaluation and the subsequent adoption of preventive measures. However, it is difficult to predict which patients are susceptible to developing swallowing alterations depending on neuroimaging findings. However, the findings have been inconsistent, mainly due to simplification in the classification of brain injuries into a small number of groups, or to the different methods employed in assessing swallowing function
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Diagnostic Test: functional endoscopic evaluation of swallow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients> (18 years). Conscious patients Stroke patients confirmed by brain imaging Stroke in the acute and sub-acute phase
Key exclusion criteria (1 listed)
- Previous stroke Non stroke dysphagia History of other neurologic disorders other than cerebrovascular disease.
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 |
|---|---|---|
| functional endoscopic evaluation of swallowfunctional endoscopic evaluation of swallow | Diagnostic test | study group |
Primary outcome
oral phase of swallow
Time frame: within 7 days
if there is residue in oral phase of swallow with fluids ,semisolids ,solids
pharyngeal phase of swallow
Time frame: within 7 days
if there is residue or penetration or aspiration post swallow with fluids ,semisolids, solids
brain imaging computed tomography CT or magnetic resonance imaging MRI
Time frame: within 7 days
brain imaging computed tomography CT or magnetic resonance imaging MRI correlation with oral phase and pharyngeal phase of swallow
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 29258372Abd-Allah F, Khedr E, Oraby MI, Bedair AS, Georgy SS, Moustafa RR. Stroke burden in Egypt: data from five epidemiological studies. Int J Neurosci. 2018 Aug;128(8):765-771. doi: 10.1080/00207454.2017.1420068. Epub 2018 Jan 4.
- Background: PubMed 34000833Hess F, Foerch C, Keil F, Seiler A, Lapa S. Association of Lesion Pattern and Dysphagia in Acute Intracerebral Hemorrhage. Stroke. 2021 Aug;52(9):2921-2929. doi: 10.1161/STROKEAHA.120.032615. Epub 2021 May 18.
- Background: PubMed 32912517Meng PP, Zhang SC, Han C, Wang Q, Bai GT, Yue SW. The Occurrence Rate of Swallowing Disorders After Stroke Patients in Asia: A PRISMA-Compliant Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105113. doi: 10.1016/j.jstrokecerebrovasdis.2020.105113. Epub 2020 Jul 9.
- Background: PubMed 30711683Wilmskoetter J, Bonilha L, Martin-Harris B, Elm JJ, Horn J, Bonilha HS. Mapping acute lesion locations to physiological swallow impairments after stroke. Neuroimage Clin. 2019;22:101685. doi: 10.1016/j.nicl.2019.101685. Epub 2019 Jan 22.
- Individual participant dataSharing planned: Undecided
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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.
ahmed M Emam, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional endoscopic evaluation of swallow in people with Stroke, Acute, run by Sohag University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact azhar E Ali, assisstant lecturer (01067042591, azhar.tamam@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral phase of swallow (time frame: within 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603377, which also lists 4 linked publications.
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 2 Nov 2022.