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
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