StrokeNCT06471309
Effect of Theta Burst Transcranial Magnetic Stimulation on Patients with Dysphagia After Stroke
A study testing Theta burst transcranial magnetic stimulation in people with Stroke and Dysphagia, run by Zhang Xiaohui at 1 site in China.
Trial summary
The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Dysphagia, Functional Near- Infrared Spectroscopy
- What is being tested?
- Theta burst transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2024to 15 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
- Age 18-80 years old
- The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
- The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
- The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
- MMSE>24, good cognitive function
- The skull is intact without craniotomy or repair
- Subject or family members sign informed consent
Who cannot join
- Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
- A history of mental illness or epilepsy
- A metal implant in the head or eye, a pacemaker or a drug pump in the body
- Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
- Ulceration or infection of the skin on the head or where the electrode is applied
- Poor compliance and inability to complete basic treatment
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 Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia
The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.
- Conditions
- Stroke, Dysphagia, Functional Near- Infrared Spectroscopy, Transcranial Magnetic Stimulation
- Being tested
- Theta burst 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.
Theta burst transcranial magnetic stimulationDevice
The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the sham stimulation group, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. When giving sham stimulation, put the coil vertically so that the coil is perpendicular to the patient's skull surface , it will not produce real therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral stimulation group | Experimental | On the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side Receives: Device: Theta burst transcranial magnetic stimulation |
| Unilateral stimulation group | Experimental | On the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side Receives: Device: Theta burst transcranial magnetic stimulation |
| Sham stimulation group | Sham comparator | On the basis of routine treatment and routine swallowing rehabilitation training, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side Receives: Device: Theta burst transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenbek Penetration-aspiration scale
The Rosenbek Penetration-aspiration scale assesses the patient's swallowing function by assessing the severity of penetration and aspiration. The results of Rosenbek Penetration-aspiration scale are divided into 8 grades from 1 to 8, and the lower the score, the better the swallowing ability.
Measured: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
Standardized Swallowing Assessment
The Standardized Swallowing Assessment scale is divided into three parts: clinical examination, water test, and normal eating, and is used to evaluate the safety and effectiveness of swallowing. The highest score of Standardized Swallowing Assessment scale is 46, and the lowest score is 18. The lower the score, the better the swallowing function.
Measured: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
functional near- infrared spectroscopy
fNIRS is a brain function detection technology, which can indirectly reflect the brain neural activity by detecting the content of oxygenated and deoxygenated hemoglobin in the cerebral cortex in real time. In this study, fNIRS was used to assess brain region activation and network connectivity characteristics during swallowing tasks.
Measured: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Aug 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion15 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.
- 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
- Lead sponsor
- Zhang Xiaohui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Xiaohui, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471309
- Sponsor's protocol ID
- 20240619
- Status last verified
- Sep 2024
- First submitted
- 19 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 Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia
- ClinicalTrials.gov ID
- NCT06471309
- Acronym / sponsor ID
- 20240619
- Conditions
- Stroke, Dysphagia, Functional Near- Infrared Spectroscopy, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zhang XiaohuiUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 24 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.
The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral stimulation group | Experimental | Device: Theta burst transcranial magnetic stimulationOn the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side |
| Unilateral stimulation group | Experimental | Device: Theta burst transcranial magnetic stimulationOn the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side |
| Sham stimulation group | Sham comparator | Device: Theta burst transcranial magnetic stimulationOn the basis of routine treatment and routine swallowing rehabilitation training, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years old
- The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
- The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
- The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
- MMSE>24, good cognitive function
Key exclusion criteria (6 listed)
- Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
- A history of mental illness or epilepsy
- A metal implant in the head or eye, a pacemaker or a drug pump in the body
- Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
- Ulceration or infection of the skin on the head or where the electrode is applied
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 |
|---|---|---|
| Theta burst transcranial magnetic stimulationThe stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the sham stimulation group, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. When giving sham stimulation, put the coil vertically so that the coil is perpendicular to the patient's skull surface , it will not produce real therapeutic effect. | Device | Bilateral stimulation group, Sham stimulation group, Unilateral stimulation group |
Primary outcome
Rosenbek Penetration-aspiration scale
Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
The Rosenbek Penetration-aspiration scale assesses the patient's swallowing function by assessing the severity of penetration and aspiration. The results of Rosenbek Penetration-aspiration scale are divided into 8 grades from 1 to 8, and the lower the score, the better the swallowing ability.
Standardized Swallowing Assessment
Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
The Standardized Swallowing Assessment scale is divided into three parts: clinical examination, water test, and normal eating, and is used to evaluate the safety and effectiveness of swallowing. The highest score of Standardized Swallowing Assessment scale is 46, and the lowest score is 18. The lower the score, the better the swallowing function.
functional near- infrared spectroscopy
Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
fNIRS is a brain function detection technology, which can indirectly reflect the brain neural activity by detecting the content of oxygenated and deoxygenated hemoglobin in the cerebral cortex in real time. In this study, fNIRS was used to assess brain region activation and network connectivity characteristics during swallowing tasks.
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
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.
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 Theta burst transcranial magnetic stimulation in people with Stroke and Dysphagia, run by Zhang Xiaohui 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 7 inclusion and 6 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. 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?
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?
Rosenbek Penetration-aspiration scale (time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.). 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.