Stroke SequelaeNCT07496762
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
A study testing Low Frequency EA, Medium Frequency EA and High Frequency EA in people with Stroke Sequelae and Deglutition Disorders, run by Kaili Chen at 1 site in China.
Trial summary
This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy
- What is being tested?
- Low Frequency EA, Medium Frequency EA and High Frequency EA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2026to 21 Dec 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI.
- Dysphagia Screening: Presence of varying degrees of dysphagia as screened by the Water Swallow Test (WST).
- Clinical Status: Conscious and stable vital signs, with the ability to cooperate with the treatment.
- Age: Aged between 18 and 80 years.
- Consent: Signed informed consent form obtained from the patient or their legal representative.
Who cannot join
- Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
- MRI Contraindications: Patients with metal implants or pacemakers in the body (contraindications for MRI).
- Bleeding Risk: Patients with bleeding tendencies or coagulation disorders.
- Blood Pressure: Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg).
- Organ Failure: Patients with severe failure of vital organs (e.g., heart, liver, or kidney failure).
- Disease Severity: Patients with critical or life-threatening stroke conditions.
- Cooperation: Patients unable to cooperate with the treatment due to severe cognitive impairment, aphasia, or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
kaili chen, +8619858165101, 1955961441@qq.com
About this study
This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.
- Being tested
- Low Frequency EA, Medium Frequency EA, High Frequency EA
- Keywords
- Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy, Electroacupuncture
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency EADevice
Also called Electroacupuncture (2Hz)
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 2 Hz (Low Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Medium Frequency EADevice
Also called Electroacupuncture (50Hz)
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 50 Hz (Medium Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
High Frequency EADevice
Also called Electroacupuncture (100Hz)
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 100 Hz (High Frequency).The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
| Study group | Role | What they receive |
|---|---|---|
| Low Frequency EA | Experimental | Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 2Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. Receives: Device: Low Frequency EA |
| Medium Frequency EA | Experimental | Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 50Hz.The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. Receives: Device: Medium Frequency EA |
| High Frequency EA | Experimental | Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 100Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. Receives: Device: High Frequency EA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Water Swallow Test (WST) Score
The WST is a screening tool for dysphagia. It assesses the ability to swallow water and the presence of coughing or choking. Scores range from 1 to 5, with higher scores indicating more severe dysphagia. Improvement is defined as a decrease in the WST score.
Measured: Baseline and Week 6 (End of treatment)
Secondary outcomes (3)
Change in Penetration-Aspiration Scale (PAS) Score via VFSS
The PAS is an 8-point scale used to describe the severity of penetration and aspiration events during a Videofluoroscopic Swallowing Study (VFSS). Lower scores indicate safer swallowing function.
Measured: Baseline and Week 6 (End of treatment)
Hyolaryngeal excursion measured by Ultrasound
B-mode ultrasound will be used to measure the anterior and superior displacement distance of the hyoid bone and larynx during swallowing. Greater displacement indicates better function of the suprahyoid muscles.
Measured: Baseline and Week 6 (End of treatment)
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways
Diffusion Tensor Imaging (DTI) will be used to measure the Fractional Anisotropy (FA) values of white matter fiber tracts connecting the bilateral precentral gyrus, insula, supramarginal gyrus, frontal lobe, and the nucleus of the solitary tract. Higher FA values indicate better structural integrity of the neural network.
Measured: Baseline and Week 6 (End of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start21 Dec 2026 (estimated)
- Primary completion21 Dec 2028 (estimated)
- Study completion21 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaili Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaili Chen, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496762
- Sponsor's protocol ID
- ZSLL-KY-2025-132-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
- ClinicalTrials.gov ID
- NCT07496762
- Acronym / sponsor ID
- ZSLL-KY-2025-132-01
- Keywords
- Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Kaili ChenUniversity, hospital or other
- Study start
- 21 Dec 2026 (estimated)
- Primary completion
- 21 Dec 2028 (estimated)
- Study completion
- 21 Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (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 randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Frequency EA | Experimental | Device: Low Frequency EAParticipants will receive electroacupuncture on the suprahyoid muscles at a frequency of 2Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
| Medium Frequency EA | Experimental | Device: Medium Frequency EAParticipants will receive electroacupuncture on the suprahyoid muscles at a frequency of 50Hz.The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
| High Frequency EA | Experimental | Device: High Frequency EAParticipants will receive electroacupuncture on the suprahyoid muscles at a frequency of 100Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI.
- Dysphagia Screening: Presence of varying degrees of dysphagia as screened by the Water Swallow Test (WST).
- Clinical Status: Conscious and stable vital signs, with the ability to cooperate with the treatment.
- Age: Aged between 18 and 80 years.
- Consent: Signed informed consent form obtained from the patient or their legal representative.
Key exclusion criteria (7 listed)
- Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
- MRI Contraindications: Patients with metal implants or pacemakers in the body (contraindications for MRI).
- Bleeding Risk: Patients with bleeding tendencies or coagulation disorders.
- Blood Pressure: Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg).
- Organ Failure: Patients with severe failure of vital organs (e.g., heart, liver, or kidney failure).
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 |
|---|---|---|
| Low Frequency EAAlso: Electroacupuncture (2Hz)Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 2 Hz (Low Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | Device | Low Frequency EA |
| Medium Frequency EAAlso: Electroacupuncture (50Hz)Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 50 Hz (Medium Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | Device | Medium Frequency EA |
| High Frequency EAAlso: Electroacupuncture (100Hz)Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 100 Hz (High Frequency).The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses. | Device | High Frequency EA |
Primary outcome
Change in Water Swallow Test (WST) Score
Time frame: Baseline and Week 6 (End of treatment)
The WST is a screening tool for dysphagia. It assesses the ability to swallow water and the presence of coughing or choking. Scores range from 1 to 5, with higher scores indicating more severe dysphagia. Improvement is defined as a decrease in the WST score.
3 secondary outcomes
Change in Penetration-Aspiration Scale (PAS) Score via VFSS
Time frame: Baseline and Week 6 (End of treatment)
Hyolaryngeal excursion measured by Ultrasound
Time frame: Baseline and Week 6 (End of treatment)
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways
Time frame: Baseline and Week 6 (End of treatment)
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 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke Sequelae
Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
Not yet recruitingPhase 2
ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
Ischemic Stroke in the Sequelae Stage
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae
Not yet recruiting
Optimization of Adaptive Rowing Seating
Spinal Cord Diseases, Spinal Cord Injuries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency EA, Medium Frequency EA and High Frequency EA in people with Stroke Sequelae and Deglutition Disorders, run by Kaili Chen 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 5 inclusion and 7 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 24 Sep 2026. 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?
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 kaili chen (+8619858165101, 1955961441@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Water Swallow Test (WST) Score (time frame: Baseline and Week 6 (End of treatment)). 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 24 Sep 2026.