Dysphagia After StrokeNCT07212634
Cerebellar Transcranial Direct Current Stimulation for Dysphagia After Supratentorial Stroke
A study testing Transcranial Direct Current Stimulation in people with Dysphagia After Stroke, run by Zhejiang Provincial People's Hospital.
Trial summary
It is estimated that 400,000 to 800,000 people worldwide develop neurogenic dysphagia annually. Stroke represents the most common etiology, with approximately 65% of acute stroke patients experiencing pharyngeal swallowing difficulties. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Dysphagia After Stroke
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with supratentorial stroke, confirmed by cranial MRI or CT as having cerebral infarction or hemorrhage;
- Stable vital signs after conventional treatment, with disease duration between 1 and 6 months;
- 30 ≤ age ≤75 years, male or female;
- Presence of dysphagia, drinking-induced coughing, and a Kubota Water Drinking Test grade of 3-5;
- Signed informed consent form.
Who cannot join
- MRI-confirmed lesion involving the cerebellum;
- Unstable vital signs;
- Significant cognitive impairment (MMSE score ≤ 24);
- Presence of swallowing apraxia;
- Unwilling or unable to cooperate with treatment, or taking any medication that may affect swallowing function or nervous system activity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Mechanisms of Cerebellar Transcranial Direct Current Stimulation for Treating Dysphagia After Supratentorial Stroke
It is estimated that 400,000 to 800,000 people worldwide develop neurogenic dysphagia annually. Stroke represents the most common etiology, with approximately 65% of acute stroke patients experiencing pharyngeal swallowing difficulties. Clinical manifestations of dysphagia vary widely in severity and may include residue, reflux, delayed swallowing initiation, aspiration, and cricopharyngeal muscle dysfunction. Due to its detrimental effects on nutrition, respiration, and psychosocial well-being, dysphagia significantly impairs patients' quality of life. Furthermore, the inability to swallow safely and efficiently can lead to serious complications such as aspiration pneumonia, malnutrition, and depression. The traditional swallowing rehabilitation treatment has limited effect in clinical practice, which makes it necessary to search for new effective swallowing methods.
Conventional swallowing rehabilitation often yields limited clinical benefits, highlighting the urgent need for more effective therapeutic strategies. Transcranial direct current stimulation (tDCS) is a non-invasive and safe neuromodulation technique that has shown promise in the field of neurorehabilitation. Its mechanisms extend beyond immediate cortical modulation and cerebral blood flow changes to include the regulation of synaptic plasticity, neurotransmitters such as glutamate and GABA, and excitability in remote subcortical regions. In recent years, tDCS has been increasingly applied to various neurological disorders, including post-stroke motor impairment, dysphagia, aphasia, depression, addiction, and spinal cord injury-related movement disorders. Currently, tDCS is being explored to elucidate its regulatory effects on cerebellar swallowing control, positioning it as a potential innovative treatment for neurogenic dysphagia.
Read the detailed description
This multicentre randomized controlled trial will enroll 76 patients with dysphagia after stroke from Zhejiang Provincial People' s Hospital. All patients will be centrally randomized to either tDCS combined with traditional swallowing rehabilitation or traditional rehabilitation alone. The tDCS group will be further divided into three subgroups based on stimulation parameters. Observation indicators will be Standardized Swallowing Assessment (SSA), videofluroscopic swallowing study (VFSS) and neuroimaging examinations including fMRI, MRS And quantitative electroencephalography (QEEG).
- Conditions
- Dysphagia After Stroke
- Being tested
- Transcranial Direct Current Stimulation, Sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Different experimental groups received tDCS stimulation at the following distinct sites: bilateral cerebellar hemispheres, bilateral cortical areas corresponding to the suprahyoid muscles, and combined bilateral cerebellar hemispheres alongside bilateral cortical areas corresponding to the suprahyoid muscles.
Stimulation parameters: 2 mA constant current, 20 minutes per session Treatment regimen: 5 sessions per week for 2 consecutive weeks
Sham tDCSOther
The patients in this group will receive sham stimulation applied to the same area for the same duration.
| Study group | Role | What they receive |
|---|---|---|
| Cerebellar tDCS Group | Experimental | This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral cerebellar hemispheres. Receives: Device: Transcranial Direct Current Stimulation |
| Cortical (Suprahyoid Muscle) tDCS Group | Active comparator | This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS targeting the cortical representation areas of the suprahyoid muscles in both cerebral hemispheres. Receives: Device: Transcranial Direct Current Stimulation |
| Combined Cerebellar and Cortical (Suprahyoid Muscle) tDCS Group | Active comparator | This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral suprahyoid muscle cortical areas and 20 minutes over the bilateral cerebellar hemispheres. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS Group | Sham comparator | This group will include 19 patients. The patients in this group received sham stimulation applied to the same area for the same duration. Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Swallowing Assessment (SSA)
Process: A clinician-administered scale performed in three sequential parts. Part 1 examines basic clinical signs (e.g., consciousness, lip closure, voluntary cough). Part 2 involves observing the patient swallowing 5ml of water three times. If no abnormalities are detected, Part 3 requires the patient to swallow 60ml of water, noting the time and signs of aspiration.
Assessment: The total score (ranging from 18 to 46) is calculated. A higher score indicates more severe swallowing impairment.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up]
Video fluroscopic swallowing study (VFSS)
Process: Patients will swallow barium-coated boluses of varying consistencies (liquid, semi-solid) under real-time X-ray (videofluoroscopy). The procedure is recorded for frame-by-frame analysis.
Assessment: The primary metric from VFSS will be the Penetration-Aspiration Scale (PAS ) score, which quantifies the depth and patient response to airway invasion. Additionally, the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale or component scores for oral and pharyngeal phase efficiency and safety may be used. A lower PAS score indicates better airway protection.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Secondary outcomes (4)
Change in Surface electromyography (sEMG)
Process: Electrodes will be placed on the skin overlying the submental muscle group (suprahyoid muscles). Patients will perform swallowing tasks (e.g. saliva swallow, water swallow) while the electrical activity of these muscles is recorded.
Assessment:
- Submental Electromyography (sEMG) Peak Amplitude (microvolts, µV): An indicator of the intensity of muscle contraction during swallowing, reflecting the degree of muscle effort.
- sEMG Burst Duration (milliseconds, ms): The time interval from the onset of muscle activation to its return to baseline levels, reflecting the coordination and efficiency of the swallowing act.
- sEMG Swallowing Waveform Morphology: The overall shape and pattern of the electrical activity signal during swallowing (e.g. a smooth, single-peak curve vs. a fragmented, multi-peak curve), used to assess the coordination of neuromuscular control. Changes in these parameters reflect improvements in the coordination and efficiency of the swallowing musculature.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Functional magnetic resonance imaging (fMRI)
Process: Using a 3.0T MRI scanner, high-resolution T1-weighted anatomical images and resting-state fMRI (rs-fMRI) data will be acquired. During rs-fMRI, patients will remain awake, relaxed, and with their eyes open, without performing any specific task.
Assessment: Analysis will focus on changes in functional connectivity (FC) within the swallowing network, particularly between the cerebellum, primary sensorimotor cortex, and brainstem. Regional changes in the amplitude of low-frequency fluctuations (ALFF) or cerebral blood flow (CBF) will also be examined to identify alterations in local neural activity.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Magnetic resonance spectroscopy (MRS)
Process: A single-voxel MRS sequence will be performed. Voxels will be placed in key regions of interest (ROIs), including the bilateral swallowing motor cortex and the cerebellar hemispheres.
Assessment: The concentrations of key neurometabolites-N-acetylaspartate (NAA, a marker of neuronal integrity), Choline (Cho, related to membrane turnover), Creatine (Cr, an energy reference), Gamma-Aminobutyric Acid (GABA, the primary inhibitory neurotransmitter), and Glutamate (Glu, the primary excitatory neurotransmitter)-will be quantified. Changes in ratios (e.g., NAA/Cr) or absolute concentrations will indicate neuroplastic and neurochemical changes.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Quantitative electroencephalography (QEEG)
Process: A 32-channel digital EEG system will record brain electrical activity for at least 10 minutes in a resting state (eyes closed). Data will be carefully inspected to remove artifacts.
Assessment: The power spectral density of key frequency bands (Delta, Theta, Alpha, Beta) will be analyzed. Primary QEEG metrics will include the Brain Symmetry Index (BSI) to assess interhemispheric balance and the Delta + Theta/Alpha+Beta Ratio (DTABR), which serves as an indicator of overall brain arousal and cortical inefficiency. A decrease in DTABR suggests a shift towards a more alert and efficient brain state.
Measured: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia After 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junmei Lai, MD, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212634
- Sponsor's protocol ID
- 2024KY739
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 8 Oct 2025
- 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Cerebellar Transcranial Direct Current Stimulation for Treating Dysphagia After Supratentorial Stroke
- ClinicalTrials.gov ID
- NCT07212634
- Acronym / sponsor ID
- 2024KY739
- Conditions
- Dysphagia After Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
It is estimated that 400,000 to 800,000 people worldwide develop neurogenic dysphagia annually. Stroke represents the most common etiology, with approximately 65% of acute stroke patients experiencing pharyngeal swallowing difficulties. Clinical manifestations of dysphagia vary widely in severity and may include residue, reflux, delayed swallowing initiation, aspiration, and cricopharyngeal muscle dysfunction. Due to its detrimental effects on nutrition, respiration, and psychosocial well-being, dysphagia significantly impairs patients' quality of life. Furthermore, the inability to swallow safely and efficiently can lead to serious complications such as aspiration pneumonia, malnutrition, and depression. The traditional swallowing rehabilitation treatment has limited effect in clinical practice, which makes it necessary to search for new effective swallowing methods.
Conventional swallowing rehabilitation often yields limited clinical benefits, highlighting the urgent need for more effective therapeutic strategies. Transcranial direct current stimulation (tDCS) is a non-invasive and safe neuromodulation technique that has shown promise in the field of neurorehabilitation. Its mechanisms extend beyond immediate cortical modulation and cerebral blood flow changes to include the regulation of synaptic plasticity, neurotransmitters such as glutamate and GABA, and excitability in remote subcortical regions. In recent years, tDCS has been increasingly applied to various neurological disorders, including post-stroke motor impairment, dysphagia, aphasia, depression, addiction, and spinal cord injury-related movement disorders. Currently, tDCS is being explored to elucidate its regulatory effects on cerebellar swallowing control, positioning it as a potential innovative treatment for neurogenic dysphagia.
Detailed description
This multicentre randomized controlled trial will enroll 76 patients with dysphagia after stroke from Zhejiang Provincial People' s Hospital. All patients will be centrally randomized to either tDCS combined with traditional swallowing rehabilitation or traditional rehabilitation alone. The tDCS group will be further divided into three subgroups based on stimulation parameters. Observation indicators will be Standardized Swallowing Assessment (SSA), videofluroscopic swallowing study (VFSS) and neuroimaging examinations including fMRI, MRS And quantitative electroencephalography (QEEG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cerebellar tDCS Group | Experimental | Device: Transcranial Direct Current StimulationThis group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral cerebellar hemispheres. |
| Cortical (Suprahyoid Muscle) tDCS Group | Active comparator | Device: Transcranial Direct Current StimulationThis group will include 19 patients. The patients in this group will receive 20 minutes of tDCS targeting the cortical representation areas of the suprahyoid muscles in both cerebral hemispheres. |
| Combined Cerebellar and Cortical (Suprahyoid Muscle) tDCS Group | Active comparator | Device: Transcranial Direct Current StimulationThis group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral suprahyoid muscle cortical areas and 20 minutes over the bilateral cerebellar hemispheres. |
| Sham tDCS Group | Sham comparator | Other: Sham tDCSThis group will include 19 patients. The patients in this group received sham stimulation applied to the same area for the same duration. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with supratentorial stroke, confirmed by cranial MRI or CT as having cerebral infarction or hemorrhage;
- Stable vital signs after conventional treatment, with disease duration between 1 and 6 months;
- 30 ≤ age ≤75 years, male or female;
- Presence of dysphagia, drinking-induced coughing, and a Kubota Water Drinking Test grade of 3-5;
- Signed informed consent form.
Key exclusion criteria (5 listed)
- MRI-confirmed lesion involving the cerebellum;
- Unstable vital signs;
- Significant cognitive impairment (MMSE score ≤ 24);
- Presence of swallowing apraxia;
- Unwilling or unable to cooperate with treatment, or taking any medication that may affect swallowing function or nervous system activity.
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 Direct Current StimulationDifferent experimental groups received tDCS stimulation at the following distinct sites: bilateral cerebellar hemispheres, bilateral cortical areas corresponding to the suprahyoid muscles, and combined bilateral cerebellar hemispheres alongside bilateral cortical areas corresponding to the suprahyoid muscles. Stimulation parameters: 2 mA constant current, 20 minutes per session Treatment regimen: 5 sessions per week for 2 consecutive weeks | Device | Cerebellar tDCS Group, Combined Cerebellar and Cortical (Suprahyoid Muscle) tDCS Group, Cortical (Suprahyoid Muscle) tDCS Group |
| Sham tDCSThe patients in this group will receive sham stimulation applied to the same area for the same duration. | Other | Sham tDCS Group |
Primary outcome
Standardized Swallowing Assessment (SSA)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up]
Process: A clinician-administered scale performed in three sequential parts. Part 1 examines basic clinical signs (e.g., consciousness, lip closure, voluntary cough). Part 2 involves observing the patient swallowing 5ml of water three times. If no abnormalities are detected, Part 3 requires the patient to swallow 60ml of water, noting the time and signs of aspiration. Assessment: The total score (ranging from 18 to 46) is calculated. A higher score indicates more severe swallowing impairment.
Video fluroscopic swallowing study (VFSS)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Process: Patients will swallow barium-coated boluses of varying consistencies (liquid, semi-solid) under real-time X-ray (videofluoroscopy). The procedure is recorded for frame-by-frame analysis. Assessment: The primary metric from VFSS will be the Penetration-Aspiration Scale (PAS ) score, which quantifies the depth and patient response to airway invasion. Additionally, the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale or component scores for oral and pharyngeal phase efficiency and safety may be used. A lower PAS score indicates better airway protection.
4 secondary outcomes
Change in Surface electromyography (sEMG)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Functional magnetic resonance imaging (fMRI)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Magnetic resonance spectroscopy (MRS)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Change in Quantitative electroencephalography (QEEG)
Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Dysphagia After Stroke, run by Zhejiang Provincial People's Hospital.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sisi Wang, PhD (86-18158510955, 415169277@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Swallowing Assessment (SSA) (time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up]). The study lists 2 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 8 Oct 2025.