DysphagiaNCT06184711
McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation
A study testing Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme and Transcranial Magnetic Stimulation in people with Dysphagia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme and Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2023to 30 Dec 2025
- 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
- Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative
Who cannot join
- Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation in Individuals With Post-Stroke Dysphagia
This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.
Read the detailed description
Stroke is a neurological disorder that causes focal or global cerebral dysfunction caused by vascular causes, can last for 24 hours or longer, or may result in death. Many complications occur after stroke, and one of the most common complications is dysphagia After dysphagia, individuals with dehydration, malnutrition, aspiration, aspiration-related pneumonia, sepsis, and even death may result if no precautions are taken. Purpose of dysphagia treatment; It is to ensure that individuals receive their daily water and calorie needs most reliably. Another goal is to switch the patient to oral nutrition as much as possible. McNeill Dysphagia Therapy Programme is a systematic exercise-based therapy program developed for individuals with dysphagia. It is also frequently used in the rehabilitation of stroke, traumatic brain injury, and post-cancer dysphagia. Transcranial Magnetic Stimulation (TMS) is based on the principle of electromagnetic induction. It is a non-invasive method that, together with the magnetic field created by a coil placed on the scalp, causes electrical stimulation in the cerebral cortex and creates neurophysiological arrangements in different parts of the brain. Without the electrode, electrical energy is transferred to the human brain and the cerebral cortex is stimulated. An action potential is created by stimulation in neuronal membranes and causes neurons to fire. Thus, nerve cells are stimulated and the process of reorganization of the brain begins. With the stimulation of the cerebral cortex, the swallowing centre is stimulated and the muscles associated with swallowing are activated. The efficacy of MDTP combined with r TMS, MDTP combined with sham r TMS and r TMS alone will be compared in the intervention of dysphagia after stroke. Patients in all three groups will be subjected to both clinical assessment tools and instrumental evaluation before and after treatment. Data will be evaluated using the Mann Swallowing Ability Assessment Test, Penetration Aspiration Scale, Functional Oral Intake Scale, Visual Analogue Scale, Dynamic Rating Scale of Swallowing Toxicity, Dysphagia Severity Rating Scale
- Conditions
- Dysphagia
- Being tested
- Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme, Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme, Transcranial Magnetic Stimulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy ProgrammeDevice
The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.
Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy ProgrammeDevice
The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.
Transcranial Magnetic StimulationDevice
Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme | Experimental | The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group. Receives: Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme |
| Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme | Sham comparator | The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group. Receives: Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme |
| Transcranial Magnetic Stimülation | Experimental | Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale
Penetration Aspiration Scale (PAS): An 8-point severity rating. Scale 1 = no substance enters the airways 8 = substance enters the airways, passes under the vocal cords without any effort to expel it.
Measured: Change from baseline from 3 weeks
Functional Oral Intake Scale
FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)
Measured: Change from baseline from 3 weeks
Dynamic Rating Scale of Swallowing Toxicity
Dynamic Imaging Grading of Ingestion Toxicity (DIGEST): residue less than 10% of the bolus = 0 point, residue less than half of the bolus = 1 point, residue less than 90% of the bolus = 2 points, residue more than 90% of the bolus = 3 points, residue in all consistencies tested = 4 points.
Measured: Change from baseline from 3 weeks
Dysphagia Severity Scale
Dysphagia Severity Scale (DSS); those ranked from "level 1" to "level 4'' are categorized into the "choking/aspiration group (severe group)". In DSS, those ranked from "level 5" to "level 7'' are categorized into the "without choking/aspiration group (mild group)".
Measured: Change from baseline from 3 weeks
Secondary outcomes (2)
Mann Swallowing Ability Assessment Test
It is used for the assessment of oro-motor/sensory prerequisite skills of swallowing, functional assessment of swallowing and dietary modifications and identification of risk factors. A score of 138 and below indicates severe dysphagia, 139-167 indicates moderate dysphagia, 168-177 indicates mild dysphagia and 178-200 indicates no abnormality in swallowing.
Measured: Change from baseline from 3 weeks
Visual Analogue Scale (VAS)
Visual Analogue Scale; Line bisection task or numerical grading.The patient 'marks' the point of current swallowing ability. He/she scores his/her swallowing from 1 to 10.
- The patient 'marks' the point of current swallowing ability. He/she scores his/her swallowing from 1 to 10.
Measured: Change from baseline from 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start29 Dec 2023 (estimated)
- Primary completion29 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Nur Şimşek, Ankara City Hospital Bilkent
- Investigators
- Kübra Nur ŞİMŞEK, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184711
- Sponsor's protocol ID
- AnkaraCHBilkentKNS
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation in Individuals With Post-Stroke Dysphagia
- ClinicalTrials.gov ID
- NCT06184711
- Acronym / sponsor ID
- AnkaraCHBilkentKNS
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 29 Dec 2023 (estimated)
- Primary completion
- 29 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Dec 2023 (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.
This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.
Detailed description
Stroke is a neurological disorder that causes focal or global cerebral dysfunction caused by vascular causes, can last for 24 hours or longer, or may result in death. Many complications occur after stroke, and one of the most common complications is dysphagia After dysphagia, individuals with dehydration, malnutrition, aspiration, aspiration-related pneumonia, sepsis, and even death may result if no precautions are taken. Purpose of dysphagia treatment; It is to ensure that individuals receive their daily water and calorie needs most reliably. Another goal is to switch the patient to oral nutrition as much as possible. McNeill Dysphagia Therapy Programme is a systematic exercise-based therapy program developed for individuals with dysphagia. It is also frequently used in the rehabilitation of stroke, traumatic brain injury, and post-cancer dysphagia. Transcranial Magnetic Stimulation (TMS) is based on the principle of electromagnetic induction. It is a non-invasive method that, together with the magnetic field created by a coil placed on the scalp, causes electrical stimulation in the cerebral cortex and creates neurophysiological arrangements in different parts of the brain. Without the electrode, electrical energy is transferred to the human brain and the cerebral cortex is stimulated. An action potential is created by stimulation in neuronal membranes and causes neurons to fire. Thus, nerve cells are stimulated and the process of reorganization of the brain begins. With the stimulation of the cerebral cortex, the swallowing centre is stimulated and the muscles associated with swallowing are activated. The efficacy of MDTP combined with r TMS, MDTP combined with sham r TMS and r TMS alone will be compared in the intervention of dysphagia after stroke. Patients in all three groups will be subjected to both clinical assessment tools and instrumental evaluation before and after treatment. Data will be evaluated using the Mann Swallowing Ability Assessment Test, Penetration Aspiration Scale, Functional Oral Intake Scale, Visual Analogue Scale, Dynamic Rating Scale of Swallowing Toxicity, Dysphagia Severity Rating Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme | Experimental | Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy ProgrammeThe McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group. |
| Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme | Sham comparator | Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy ProgrammeThe McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group. |
| Transcranial Magnetic Stimülation | Experimental | Device: Transcranial Magnetic StimulationOnly Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative
Key exclusion criteria (1 listed)
- Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
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 |
|---|---|---|
| Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy ProgrammeThe McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group. | Device | Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme |
| Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy ProgrammeThe McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group. | Device | Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme |
| Transcranial Magnetic StimulationOnly Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group. | Device | Transcranial Magnetic Stimülation |
Primary outcome
Penetration Aspiration Scale
Time frame: Change from baseline from 3 weeks
Penetration Aspiration Scale (PAS): An 8-point severity rating. Scale 1 = no substance enters the airways 8 = substance enters the airways, passes under the vocal cords without any effort to expel it.
Functional Oral Intake Scale
Time frame: Change from baseline from 3 weeks
FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)
Dynamic Rating Scale of Swallowing Toxicity
Time frame: Change from baseline from 3 weeks
Dynamic Imaging Grading of Ingestion Toxicity (DIGEST): residue less than 10% of the bolus = 0 point, residue less than half of the bolus = 1 point, residue less than 90% of the bolus = 2 points, residue more than 90% of the bolus = 3 points, residue in all consistencies tested = 4 points.
Dysphagia Severity Scale
Time frame: Change from baseline from 3 weeks
Dysphagia Severity Scale (DSS); those ranked from "level 1" to "level 4'' are categorized into the "choking/aspiration group (severe group)". In DSS, those ranked from "level 5" to "level 7'' are categorized into the "without choking/aspiration group (mild group)".
2 secondary outcomes
Mann Swallowing Ability Assessment Test
Time frame: Change from baseline from 3 weeks
Visual Analogue Scale (VAS)
Time frame: Change from baseline from 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
Kübra Nur ŞİMŞEK principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme and Transcranial Magnetic Stimulation in people with Dysphagia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 28 Dec 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 Kübra Nur ŞİMŞEK (+905543454446 ext. 03125526000, kbranrsimsek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (time frame: Change from baseline from 3 weeks). The study lists 4 primary outcomes in all. 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 28 Dec 2023.