StrokeNCT06464835
Effects of ITBS Combined with NMES on Dysphagia After Stroke
A study testing Transcranial magnetic stimulation in people with Stroke and Dysphagia, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency （repetitive transcranial magnetic stimulation，rTMS） stimulation paradigm, has focused on exploring the effects in healthy people. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Dysphagia, Intermittent Theta Burst Stimulation
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2024to 1 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ~80 years old;
- The patients met the diagnostic criteria of stroke in the "Diagnostic Points for Major Cerebrovascular Diseases in China 2019" formulated by the Chinese Society of Neurology, and were confirmed by head CT or MRI;
- The patients met the diagnostic criteria of dysphagia in the "Chinese Expert Consensus on the Evaluation and treatment of Dysphagia (2017 edition)" and were confirmed by VFSS;
- The disease duration ranged from 2 weeks to 6 months;
- The vital signs of the patient were stable;
- The score of mini-mental state examination (MMSE) was more than 17 points for the illiterate, more than 20 points for the primary scholar, and more than 24 points for the secondary school or above;
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- Can independently or under the auxiliary balance the seat 30 minutes or more;
- The skull was intact without craniotomy and/or cranioplasty;
- Informed consent was obtained from all subjects or their families.
Who cannot join
- A history of other diseases that may cause dysphagia, such as Parkinson's disease, head and neck radiotherapy, or other neurological diseases;
- Contraindications to iTBS or NMES with a history of epilepsy, intracranial metal implants, bleeding tendency, etc.;
- Skin damage and infection on the front of the neck affect the placement of the surface electrode;
- Such as fever, important viscera function failure condition is not stable, or critically ill.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450044
About this study
Official title: Effect of ITBS Combined with NMES on Post-stroke Dysphagia and Corresponding Neural Network
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency （repetitive transcranial magnetic stimulation，rTMS） stimulation paradigm, has focused on exploring the effects in healthy people. Based on previous studies, it is believed that the central magnetic stimulation combined with peripheral electrical stimulation based on the "central-peripheral-central" closed-loop rehabilitation concept has the best effect, but there are few clinical studies on the efficacy and mechanism of iTBS combined treatment of dysphagia after stroke, and the selection of the optimal stimulation scheme and target has not yet been determined, therefore, this study aims to observe the efficacy and mechanism of implementation of iTBS combined with neuromuscular electrical stimulation (NMES) on with patients with dysphagia (PSD) .
Read the detailed description
The purpose of this study is to observe the effect of intermittent Theta Burst Stimulation (iTBS) combined with neuromuscular electrical stimulation (NMES) on patients with dysphagia (PSD) after stroke, and to detect the activation of related swallowing networks in patients with PSD after receiving iTBS combined with NMES by functional near-infrared spectroscopy (fNIRS), and to explore the possible mechanism of PSD treatment, so as to provide a theoretical basis for finding the best, specific and individualized treatment plan for the treatment of PSD patients. Promote the functional recovery of patients, reduce complications, and promote the prognosis of diseases.
Patients who withdrew treatment for any reason other than progression (other than withdrawal of consent or loss to follow-up) continued to undergo objective assessment every 8 weeks to collect information on disease progression. Investigators were required to collect long-term follow-up information on survival by telephone at least every 12 weeks after documentation of disease progression by contacting patients, family members, or the patient's current treating physician.
Subjects who have the right to withdraw from the trial in the middle of the trial, or who are no longer tested and are lost to follow-up even though they have not explicitly proposed to withdraw from the trial, are also considered "withdrawal" (or "dropout"). The reasons for their withdrawal should be known as much as possible and documented. If the withdrawal is due to an adverse event, the patient should be visited for examination until the pre-treatment status or no clinical significance, and the adverse event form should be completed. The cause of the absconted case should be recorded in detail, and the informed consent form, original medical record, and case report form should be retained for future reference.
Treatment of drop-off cases: (1) When the subject falls off, the investigator should contact the subject to inquire about the reason as much as possible by visiting the door to make an appointment by telephone or letter. (2) If the experimental case is withdrawn due to allergic reactions, adverse reactions, or ineffective treatment, the investigator shall take corresponding treatment measures according to the actual situation of the subject. (3) The investigator should fill in the record of the main reason for discontinuing the trial. (4) All patients who have been selected and have been numbered, regardless of whether they have dropped out or not, should be recorded and kept for observation, both for filing and for intention-to-intention analysis (ITT), and all shedding cases should be summarized and statistically analyzed.
The sample size was calculated using G-power software based on the references.SPSS software was used for statistical description and analysis. Count data were expressed as rates or percentages, and chi-square tests were used for comparisons between groups. If the data conform to the normal distribution and the variance is homogeneous, (x̅ ± s) is used to express the continuous data, the one-way ANOVA was used for comparison between multiple groups, the least-significant difference (LSD) method was used for subsequent pairwise comparisons, and the paired sample t-test was used for comparison before and after treatment within the group. If the normal distribution is not conformed, the median and quartile M(P25,P75) are used, and the rank sum test is used. A P value of less than 0.05 indicated that the difference was statistically significant. The task state data processing of （functional near-infrared spectroscopy，fNIRS） is run by NirSpark toolkit software for data preprocessing. is run by NirSpark toolkit software for data preprocessing.
- Conditions
- Stroke, Dysphagia, Intermittent Theta Burst Stimulation, Neuromuscular Electrical Stimulation, Functional Near-infrared Spectroscopy
- Being tested
- Transcranial magnetic stimulation
- 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.
Transcranial magnetic stimulationDevice
The treatment parameter for iTBS was 80% stimulus intensity. The stimulation frequency was 50Hz in the plexus and 5Hz in the interplexus. Each burst stimulus consisted of 3 consecutive pulses, 2s stimulus, 8s interval, and repeated 20 times, a total of 600 pulses, and the duration of stimulation was 189s. NMES treatment parameters for output waveform for two-way square wave, wave width 700 ms, positive and negative half wave (300 ms) between 100 ms intermittent, stimulating frequency 50 hz, treatment when the output intensity range of 0 ~ 25 ma, stimulating electrodes pasted in bilateral mandibular hyoid muscle movement points, output intensity in patients with tongue bone muscle group it is advisable to have a sense of fashion, extrusion. Each treatment lasted 30 minutes, once a day, 5 times a week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| iTBS combined with NMES | Experimental | On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes Receives: Device: Transcranial magnetic stimulation |
| iTBS combined with sham NMES | Experimental | On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES sham stimulation for 30 minutes after 10 minutes Receives: Device: Transcranial magnetic stimulation |
| sham iTBS combined with NMES | Experimental | On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with sham iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional near-infrared spectroscopy
Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technology based on blood vessels, which can be used to evaluate the activation of brain regions associated with swallowing
Measured: immediately before and immediately after the intervention
Standardized Swallowing Assessment Scale
The Standard Swallowing Assessment Scale is a method of assessing a patient's swallowing function. During the assessment, the patient's level of consciousness, head and trunk control, breathing patterns, lip closure, soft palate movements, laryngeal function, gag reflex, and voluntary cough should be recorded.The highest score on the scale is 46 points, and the lowest score is 18 points, and the lower the score, the better the swallowing function.
Measured: immediately before and immediately after the intervention
The Yale Pharyngeal Residue Severity Rating Scale
The Yale Pharyngeal Residue Severity Rating Scale is a laryngoscopy-based assessment scale used to assess the degree of food residue.The scale divided the residues of the valley of the eglottis and the piriform fossa into grades 1-5 according to the severity of the scale, respectively. The higher the grade, the more severe the food residue
Measured: immediately before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start3 Aug 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Xiu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464835
- Sponsor's protocol ID
- 2024-6-11
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ITBS Combined with NMES on Post-stroke Dysphagia and Corresponding Neural Network
- ClinicalTrials.gov ID
- NCT06464835
- Acronym / sponsor ID
- 2024-6-11
- Conditions
- Stroke, Dysphagia, Intermittent Theta Burst Stimulation, Neuromuscular Electrical Stimulation, Functional Near-infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Jun 2024 (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.
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency （repetitive transcranial magnetic stimulation，rTMS） stimulation paradigm, has focused on exploring the effects in healthy people. Based on previous studies, it is believed that the central magnetic stimulation combined with peripheral electrical stimulation based on the "central-peripheral-central" closed-loop rehabilitation concept has the best effect, but there are few clinical studies on the efficacy and mechanism of iTBS combined treatment of dysphagia after stroke, and the selection of the optimal stimulation scheme and target has not yet been determined, therefore, this study aims to observe the efficacy and mechanism of implementation of iTBS combined with neuromuscular electrical stimulation (NMES) on with patients with dysphagia (PSD) .
Detailed description
The purpose of this study is to observe the effect of intermittent Theta Burst Stimulation (iTBS) combined with neuromuscular electrical stimulation (NMES) on patients with dysphagia (PSD) after stroke, and to detect the activation of related swallowing networks in patients with PSD after receiving iTBS combined with NMES by functional near-infrared spectroscopy (fNIRS), and to explore the possible mechanism of PSD treatment, so as to provide a theoretical basis for finding the best, specific and individualized treatment plan for the treatment of PSD patients. Promote the functional recovery of patients, reduce complications, and promote the prognosis of diseases.
Patients who withdrew treatment for any reason other than progression (other than withdrawal of consent or loss to follow-up) continued to undergo objective assessment every 8 weeks to collect information on disease progression. Investigators were required to collect long-term follow-up information on survival by telephone at least every 12 weeks after documentation of disease progression by contacting patients, family members, or the patient's current treating physician.
Subjects who have the right to withdraw from the trial in the middle of the trial, or who are no longer tested and are lost to follow-up even though they have not explicitly proposed to withdraw from the trial, are also considered "withdrawal" (or "dropout"). The reasons for their withdrawal should be known as much as possible and documented. If the withdrawal is due to an adverse event, the patient should be visited for examination until the pre-treatment status or no clinical significance, and the adverse event form should be completed. The cause of the absconted case should be recorded in detail, and the informed consent form, original medical record, and case report form should be retained for future reference.
Treatment of drop-off cases: (1) When the subject falls off, the investigator should contact the subject to inquire about the reason as much as possible by visiting the door to make an appointment by telephone or letter. (2) If the experimental case is withdrawn due to allergic reactions, adverse reactions, or ineffective treatment, the investigator shall take corresponding treatment measures according to the actual situation of the subject. (3) The investigator should fill in the record of the main reason for discontinuing the trial. (4) All patients who have been selected and have been numbered, regardless of whether they have dropped out or not, should be recorded and kept for observation, both for filing and for intention-to-intention analysis (ITT), and all shedding cases should be summarized and statistically analyzed.
The sample size was calculated using G-power software based on the references.SPSS software was used for statistical description and analysis. Count data were expressed as rates or percentages, and chi-square tests were used for comparisons between groups. If the data conform to the normal distribution and the variance is homogeneous, (x̅ ± s) is used to express the continuous data, the one-way ANOVA was used for comparison between multiple groups, the least-significant difference (LSD) method was used for subsequent pairwise comparisons, and the paired sample t-test was used for comparison before and after treatment within the group. If the normal distribution is not conformed, the median and quartile M(P25,P75) are used, and the rank sum test is used. A P value of less than 0.05 indicated that the difference was statistically significant. The task state data processing of （functional near-infrared spectroscopy，fNIRS） is run by NirSpark toolkit software for data preprocessing. is run by NirSpark toolkit software for data preprocessing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iTBS combined with NMES | Experimental | Device: Transcranial magnetic stimulationOn the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes |
| iTBS combined with sham NMES | Experimental | Device: Transcranial magnetic stimulationOn the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES sham stimulation for 30 minutes after 10 minutes |
| sham iTBS combined with NMES | Experimental | Device: Transcranial magnetic stimulationOn the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with sham iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 ~80 years old;
- The patients met the diagnostic criteria of stroke in the "Diagnostic Points for Major Cerebrovascular Diseases in China 2019" formulated by the Chinese Society of Neurology, and were confirmed by head CT or MRI;
- The patients met the diagnostic criteria of dysphagia in the "Chinese Expert Consensus on the Evaluation and treatment of Dysphagia (2017 edition)" and were confirmed by VFSS;
- The disease duration ranged from 2 weeks to 6 months;
- The vital signs of the patient were stable;
Key exclusion criteria (4 listed)
- A history of other diseases that may cause dysphagia, such as Parkinson's disease, head and neck radiotherapy, or other neurological diseases;
- Contraindications to iTBS or NMES with a history of epilepsy, intracranial metal implants, bleeding tendency, etc.;
- Skin damage and infection on the front of the neck affect the placement of the surface electrode;
- Such as fever, important viscera function failure condition is not stable, or critically ill.
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 stimulationThe treatment parameter for iTBS was 80% stimulus intensity. The stimulation frequency was 50Hz in the plexus and 5Hz in the interplexus. Each burst stimulus consisted of 3 consecutive pulses, 2s stimulus, 8s interval, and repeated 20 times, a total of 600 pulses, and the duration of stimulation was 189s. NMES treatment parameters for output waveform for two-way square wave, wave width 700 ms, positive and negative half wave (300 ms) between 100 ms intermittent, stimulating frequency 50 hz, treatment when the output intensity range of 0 ~ 25 ma, stimulating electrodes pasted in bilateral mandibular hyoid muscle movement points, output intensity in patients with tongue bone muscle group it is advisable to have a sense of fashion, extrusion. Each treatment lasted 30 minutes, once a day, 5 times a week for 2 weeks. | Device | iTBS combined with NMES, iTBS combined with sham NMES, sham iTBS combined with NMES |
Primary outcome
functional near-infrared spectroscopy
Time frame: immediately before and immediately after the intervention
Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technology based on blood vessels, which can be used to evaluate the activation of brain regions associated with swallowing
Standardized Swallowing Assessment Scale
Time frame: immediately before and immediately after the intervention
The Standard Swallowing Assessment Scale is a method of assessing a patient's swallowing function. During the assessment, the patient's level of consciousness, head and trunk control, breathing patterns, lip closure, soft palate movements, laryngeal function, gag reflex, and voluntary cough should be recorded.The highest score on the scale is 46 points, and the lowest score is 18 points, and the lower the score, the better the swallowing function.
The Yale Pharyngeal Residue Severity Rating Scale
Time frame: immediately before and immediately after the intervention
The Yale Pharyngeal Residue Severity Rating Scale is a laryngoscopy-based assessment scale used to assess the degree of food residue.The scale divided the residues of the valley of the eglottis and the piriform fossa into grades 1-5 according to the severity of the scale, respectively. The higher the grade, the more severe the food residue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Stroke and Dysphagia, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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 9 inclusion and 4 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 27 Sep 2024. 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 China. 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?
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?
functional near-infrared spectroscopy (time frame: immediately before and immediately after the intervention). 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?
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 27 Sep 2024.