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Not yet recruitingNCT07496762Updated Sep 24, 2026

Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks

An interventional study of Low Frequency EA and Medium Frequency EA in Stroke Sequelae, Deglutition Disorders and Acupuncture Therapy, sponsored by Kaili Chen. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Kaili Chen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Deglutition Disorders with a site in China — 21 open to participants now, 23 under way, none of them phase 3. Deglutition Disorders · China.

Planned enrollment
15th of 48
102 · median 71
Started
2026
with 6 others
No phase
39 of 54
14 open now
Primary completion
2028-12
later than 19 of 22 live
Registered
50th of 54
by date

Among the 54 studies in Deglutition Disorders with a site in China, this one is the 15th largest by planned enrollment of the 48 interventional ones, is one of 7 that started in 2026, is one of 39 with no phase, reaches primary completion later than 19 of the 22 other live ones, and was the 50th registered.

By phase

54 studies; the count open now beside each. This study's row is marked.

No phasethis study39 · 14 open
Observational6 · 3 open
Phase 25 · 3 open
Phase 33 · 0 open
Phase 41 · 1 open

By the year they started

First in 2004; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 71 across the 48 interventional studies, 35 across the 6 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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. 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.

03

Conditions studied

  • Stroke Sequelae
  • Deglutition Disorders
  • Acupuncture Therapy
  • Electroacupuncture

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Keywords

  • Stroke Sequelae
  • Deglutition Disorders
  • Acupuncture Therapy
  • Electroacupuncture
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form obtained from the patient or their legal representative.

Exclusion criteria

Exclusion Criteria:

  • Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
  • MRI : 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Low Frequency EA

    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.

    Device: Low Frequency EA

  • Experimental
    Medium Frequency EA

    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.

    Device: Medium Frequency EA

  • Experimental
    High Frequency EA

    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.

    Device: High Frequency EA

Interventions

  • DeviceLow Frequency EA

    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.

    Also known as: Electroacupuncture (2Hz)

  • DeviceMedium Frequency EA

    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.

    Also known as: Electroacupuncture (50Hz)

  • DeviceHigh Frequency EA

    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.

    Also known as: Electroacupuncture (100Hz)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 6 (End of treatment)

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 6 (End of treatment)

  2. 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.

    Time frame: Baseline and Week 6 (End of treatment)

  3. 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.

    Time frame: Baseline and Week 6 (End of treatment)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 24 months is above that.

Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2026
First posted
Mar 27, 2026
StartEst.
Dec 21, 2026
Primary completionEst.
Dec 21, 2028
CompletionEst.
Dec 21, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07496762
Lead sponsor
Kaili Chen
Responsible party
Kaili Chen (resident physician, The Third Affiliated hospital of Zhejiang Chinese Medical University) — Sponsor-investigator
First posted
Mar 27, 2026
Start date
Dec 21, 2026 (estimated)
Primary completion
Dec 21, 2028 (estimated)
Completion
Dec 21, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

kaili chen
Contact
1955961441@qq.com
+8619858165101

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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