DysphagiaNMESWALNCT07445204
Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Muscles and Swallowing Function in Acute Hemiparetic Stroke Patients
A study testing Conventional Swallowing Therapy, Vitalstim-Sensory NMES and Vitalstim-Motor NMES in people with Dysphagia and Stroke, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the effects of sensory, motor, and modified combined neuromuscular electrical stimulation (NMES) protocols on swallowing function in patients with acute stroke-related dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Stroke, Hemiparesis
- What is being tested?
- Conventional Swallowing Therapy, Vitalstim-Sensory NMES and Vitalstim-Motor NMES
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, Diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) within the past month, Modified Rankin Scale score ≤ 2, NIH Stroke Scale (NIHSS) score ≤ 25, Gugging Swallowing Screen (GUSS) score < 20, Ability to maintain upright sitting position during VFSS and therapy sessions, Voluntary participation with signed informed consent
Who cannot join
- History of secondary stroke, Inability to follow simple verbal commands Unstable medical condition, History of head or neck cancer, neoplastic tissue growth, or epileptic seizures, Presence of musculoskeletal disorders affecting the neck or swallowing muscles, Cognitive impairment indicated by an IQCODE score > 3.4, Any neurological disease other than stroke that may cause swallowing disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstinye University Hospital, Acute Stroke Center
Istanbul
About this study
This randomized controlled trial aims to investigate the effects of sensory, motor, and modified combined neuromuscular electrical stimulation (NMES) protocols on swallowing function in patients with acute stroke-related dysphagia. The study compares traditional swallowing rehabilitation alone with three NMES-assisted intervention protocols to determine their impact on swallowing safety, efficiency, and rehabilitation outcomes. Ultrasonographic assessment of hyoid-laryngeal motion will be used as the primary instrumental outcome.
Read the detailed description
This randomized controlled, double-blind clinical trial aims to investigate the effects of different neuromuscular electrical stimulation (NMES) protocols-sensory, motor, and modified combined-on the swallowing function and suprahyoid muscle morphology in patients with acute hemiparetic stroke. Dysphagia is one of the most common and serious complications following stroke, leading to nutritional deficiencies, aspiration risk, and reduced quality of life. NMES has been increasingly used in dysphagia rehabilitation as a noninvasive technique that facilitates both peripheral muscle activation and central neuroplasticity.
A total of 40 acute hemiparetic stroke patients diagnosed with dysphagia will be recruited from the Acute Stroke Center of Istinye University Liv Hospital and randomly assigned to four groups:
Group 1: Sensory stimulation (submotor level, below contraction threshold) Group 2: Motor stimulation (supramotor level, visible contraction) Group 3: Modified combined stimulation (motor stimulation on the paretic side and sensory stimulation on the contralateral side) Group 4: Control group (conventional swallowing rehabilitation only) All intervention groups will receive NMES in addition to conventional dysphagia therapy for 10 sessions (40 minutes each). NMES parameters will be standardized as follows: channel mode co-contraction, frequency 80 Hz, pulse duration 180 μs, on-time 3 seconds, and off-time 20 seconds. Electrodes will be placed bilaterally, with the upper pair located above the hyoid bone and the lower pair over the thyrohyoid muscle.
The primary outcome measures will include ultrasonographic assessment of the suprahyoid muscles (muscle thickness, cross-sectional area, echo intensity, and shear-wave elasticity) and dynamic analysis of hyoid-laryngeal movement during swallowing of 5 mL boluses with standardized viscosity levels (IDDSI Level 0 and 4). Measurements will be performed using a LOGIQ P8 ultrasound system with B- and M-mode imaging according to Matsuo's hyoid-laryngeal motion index method.
The secondary outcome measures include videofluoroscopic swallowing study (VFSS) parameters such as the Penetration-Aspiration Scale (PAS), Bolus Residue Scale (BRS), and DIGEST scale, as well as clinical assessments like the Functional Oral Intake Scale (FOIS) and a Nurse Evaluation Form assessing perceived functional improvement via a visual analog scale.
Randomization will be computer-generated (randomizer.org), and all outcome assessments will be conducted by blinded evaluators. The intervention will be delivered by an experienced physiotherapist specialized in dysphagia management.
This study aims to provide comparative evidence on how different NMES stimulation types influence swallowing safety, efficiency, and muscle adaptation in acute stroke. By integrating instrumental (ultrasound and VFSS) and clinical outcomes, the findings will help identify the most effective NMES protocol and contribute to the development of individualized, evidence-based rehabilitation approaches for neurogenic dysphagia.
- Conditions
- Dysphagia, Stroke, Hemiparesis
- Being tested
- Conventional Swallowing Therapy, Vitalstim-Sensory NMES, Vitalstim-Motor NMES, Vitalstim-Combine NMES
- Keywords
- Dysphagia, Stroke, Neuromuscular Electrical Stimulation (NMES), Ultrasound Evaluation, Videofluoroscopic Swallow Study (VFSS), Swallowing Rehabilitation
- Medical subject headings
- Deglutition Disorders, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Swallowing TherapyBehavioural
Participants receive only conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional swallowing therapy consists of structured swallowing exercises and compensatory strategies administered by a therapist, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. Sessions last approximately 30 minutes for a total of 10 sessions.
Vitalstim-Sensory NMESDevice
Participants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Stimulation is delivered at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions.
In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated.
Vitalstim-Motor NMESDevice
Participants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator, eliciting visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions.
In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated.
Vitalstim-Combine NMESDevice
Participants receive combined neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Motor-level NMES is applied to the hemiparetic side, while sensory-level NMES is applied to the contralateral side within the same session. Sessions last approximately 30 minutes for a total of 10 sessions.
In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Sensory NMES Group | Experimental | Participants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The stimulation is delivered at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. Receives: Device: Vitalstim-Sensory NMES |
| Motor NMES Group | Experimental | Participants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The stimulation is delivered at motor threshold with visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. Receives: Device: Vitalstim-Motor NMES |
| Combined NMES Group | Experimental | Participants receive combined neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Motor-level NMES is applied to the hemiparetic side at motor threshold with visible muscle contraction, while sensory-level NMES is applied simultaneously to the contralateral (non-hemiparetic) side at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. Receives: Device: Vitalstim-Combine NMES |
| Control Group | Active comparator | Participants receive conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional therapy includes traditional swallowing exercises and compensatory strategies administered by a therapist, such as effortful swallow, Mendelsohn maneuver, and tongue base exercises. Sessions last approximately 30 minutes for a total of 10 sessions. Receives: Behavioral: Conventional Swallowing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suprahyoid Muscle Thickness
Suprahyoid muscle thickness will be quantitatively measured using B-mode ultrasonography (LOGIQ P8, GE Healthcare). Measurements will be obtained at standardized anatomical landmarks by a trained examiner while participants are in a supine position with the head in neutral alignment. Thickness values will be recorded in millimeters and averaged over repeated measurements to assess morphological changes following the intervention.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Suprahyoid Muscle Cross-Sectional Area
The cross-sectional area of the suprahyoid muscle group will be assessed using B-mode ultrasonography. Images will be captured in the transverse plane, and cross-sectional area will be calculated using image analysis software. This outcome reflects structural adaptations of the swallowing-related musculature in response to different NMES protocols.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Suprahyoid Muscle Echogenicity
Muscle echogenicity will be evaluated through grayscale analysis of B-mode ultrasound images. Mean grayscale values will be calculated to reflect muscle quality, with higher echogenicity indicating increased intramuscular connective or fatty tissue. Changes in echogenicity will be used as an indicator of muscle composition and structural integrity.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Suprahyoid Muscle Stiffness
Muscle stiffness will be assessed using shear wave elastography (SWE). Quantitative stiffness values (expressed in kilopascals) will be obtained from the suprahyoid muscle region during rest. SWE measurements provide information on the mechanical properties of muscle tissue and potential neuromuscular adaptations following NMES.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Penetration-Aspiration Scale (PAS) Score
Swallowing safety will be evaluated using Videofluoroscopic Swallowing Study (VFSS) performed by an experienced clinician according to standardized protocols. Participants will swallow standardized bolus volumes and consistencies based on the International Dysphagia Diet Standardisation Initiative (IDDSI) framework. VFSS recordings will be analyzed frame-by-frame, and airway invasion severity will be rated using the Penetration-Aspiration Scale (PAS), which ranges from 1 (no airway entry) to 8 (silent aspiration). PAS scores will be used to quantify changes in airway protection following the intervention.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Bolus Residue Scale (BRS) Score
Pharyngeal residue severity will be assessed during VFSS using the Bolus Residue Scale (BRS). VFSS examinations will include multiple swallows of standardized boluses across different IDDSI consistencies. Post-swallow residue will be evaluated in predefined anatomical regions and scored according to the BRS criteria to quantify bolus clearance efficiency and residue severity.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score
Overall swallowing function will be assessed using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) during VFSS. DIGEST scoring integrates VFSS-derived measures of airway invasion (PAS) and pharyngeal residue severity to provide a global classification of swallowing safety and efficiency. VFSS recordings will be reviewed by trained raters using standardized criteria.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Secondary outcomes (2)
Changes in Functional Oral Intake Scale (FOIS)
Functional Oral Intake Scale (FOIS) will be used to evaluate changes in patients' functional oral intake level and dietary restrictions. The FOIS is a 7-point ordinal scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restrictions). The scale reflects the patient's ability to safely consume food and liquids orally in daily life. FOIS scores will be determined based on clinical evaluation, dietary intake records, and multidisciplinary team assessment, reflecting functional swallowing performance outside the instrumental assessment setting.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Changes in Nurse Observation Form for Swallowing Function
Swallowing-related functional changes will be assessed using a Nurse Observation Form completed by trained nursing staff during routine meals. The form evaluates observable swallowing-related behaviors and signs, including oral control, coughing or choking episodes, voice quality changes after swallowing, secretion management, and overall feeding tolerance. The Nurse Observation Form provides real-world, bedside information on swallowing safety and functional performance during daily oral intake.
Measured: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Model description
- Participants will be randomly assigned to one of four parallel groups. Each group will receive a different intervention protocol: sensory NMES, motor NMES, combined NMES, or control (traditional swallowing therapy only). Interventions will be applied independently to each group throughout the study period without crossover between groups. The study is designed to compare the effects of different NMES stimulation types on swallowing function in post-stroke patients with dysphagia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University, Hacettepe University
- Responsible party
- Principal investigator, Rabia KUM GULER, Istanbul Arel University
- Investigators
- Rabia KUM GÜLER, PhD(c), PT, Study director, Istanbul Arel U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445204
- Sponsor's protocol ID
- IstanbulArelU-ETK-2025/47
- Acronym
- NMESWAL
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request and approval from the principal investigator and relevant ethics committee.
Publications
Bulow M, Speyer R, Baijens L, Woisard V, Ekberg O. Neuromuscular electrical stimulation (NMES) in stroke patients with oral and pharyngeal dysfunction. Dysphagia. 2008 Sep;23(3):302-9. doi: 10.1007/s00455-007-9145-9. Epub 2008 Apr 25.
PubMed 18437464Doan TN, Ho WC, Wang LH, Chang FC, Tran TTQ, Chou LW. Therapeutic Effect and Optimal Electrode Placement of Transcutaneous Neuromuscular Electrical Stimulation in Patients with Post-Stroke Dysphagia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Life (Basel). 2022 Jun 10;12(6):875. doi: 10.3390/life12060875.
PubMed 35743906Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
PubMed 11309186Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7.
PubMed 27271373Howard MM, Block ES, Mishreki D, Kim T, Rosario ER. The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients with Dysphagia: A Randomized Trial. Dysphagia. 2023 Jun;38(3):943-953. doi: 10.1007/s00455-022-10520-7. Epub 2022 Sep 20.
PubMed 36127447Ichikawa Y, Kikutani T, Sumi M, Iwata H, Takahashi N, Tohara T, Ozeki M, Tamura F. Intramuscular condition of swallowing-related muscles using shear-wave elastography: A preliminary study in healthy adults. J Oral Rehabil. 2024 Nov;51(11):2405-2414. doi: 10.1111/joor.13844. Epub 2024 Aug 16.
PubMed 39152545Lim KB, Lee HJ, Lim SS, Choi YI. Neuromuscular electrical and thermal-tactile stimulation for dysphagia caused by stroke: a randomized controlled trial. J Rehabil Med. 2009 Feb;41(3):174-8. doi: 10.2340/16501977-0317.
PubMed 19229451Lim KB, Lee HJ, Yoo J, Kwon YG. Effect of Low-Frequency rTMS and NMES on Subacute Unilateral Hemispheric Stroke With Dysphagia. Ann Rehabil Med. 2014 Oct;38(5):592-602. doi: 10.5535/arm.2014.38.5.592. Epub 2014 Oct 30.
PubMed 25379488Matsuo T, Matsuyama M. Detection of poststroke oropharyngeal dysphagia with swallowing screening by ultrasonography. PLoS One. 2021 Mar 17;16(3):e0248770. doi: 10.1371/journal.pone.0248770. eCollection 2021.
PubMed 33730038Mayans D, Cartwright MS, Walker FO. Neuromuscular ultrasonography: quantifying muscle and nerve measurements. Phys Med Rehabil Clin N Am. 2012 Feb;23(1):133-48, xii. doi: 10.1016/j.pmr.2011.11.009. Epub 2011 Dec 9.
PubMed 22239880Meng P, Zhang S, Wang Q, Wang P, Han C, Gao J, Yue S. The effect of surface neuromuscular electrical stimulation on patients with post-stroke dysphagia. J Back Musculoskelet Rehabil. 2018;31(2):363-370. doi: 10.3233/BMR-170788.
PubMed 29278871Permsirivanich W, Tipchatyotin S, Wongchai M, Leelamanit V, Setthawatcharawanich S, Sathirapanya P, Phabphal K, Juntawises U, Boonmeeprakob A. Comparing the effects of rehabilitation swallowing therapy vs. neuromuscular electrical stimulation therapy among stroke patients with persistent pharyngeal dysphagia: a randomized controlled study. J Med Assoc Thai. 2009 Feb;92(2):259-65.
PubMed 19253803Simonelli M, Ruoppolo G, Iosa M, Morone G, Fusco A, Grasso MG, Gallo A, Paolucci S. A stimulus for eating. The use of neuromuscular transcutaneous electrical stimulation in patients affected by severe dysphagia after subacute stroke: A pilot randomized controlled trial. NeuroRehabilitation. 2019;44(1):103-110. doi: 10.3233/NRE-182526.
PubMed 30714980Taljanovic MS, Gimber LH, Becker GW, Latt LD, Klauser AS, Melville DM, Gao L, Witte RS. Shear-Wave Elastography: Basic Physics and Musculoskeletal Applications. Radiographics. 2017 May-Jun;37(3):855-870. doi: 10.1148/rg.2017160116.
PubMed 28493799Umay EK, Yaylaci A, Saylam G, Gundogdu I, Gurcay E, Akcapinar D, Kirac Z. The effect of sensory level electrical stimulation of the masseter muscle in early stroke patients with dysphagia: A randomized controlled study. Neurol India. 2017 Jul-Aug;65(4):734-742. doi: 10.4103/neuroindia.NI_377_16.
PubMed 28681742
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Muscles and Swallowing Function in Acute Hemiparetic Stroke Patients
- ClinicalTrials.gov ID
- NCT07445204
- Acronym / sponsor ID
- NMESWAL / IstanbulArelU-ETK-2025/47
- Conditions
- Dysphagia, Stroke, Hemiparesis
- Keywords
- Dysphagia, Stroke, Neuromuscular Electrical Stimulation (NMES), Ultrasound Evaluation, Videofluoroscopic Swallow Study (VFSS), Swallowing Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Istinye University, Hacettepe University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 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 trial aims to investigate the effects of sensory, motor, and modified combined neuromuscular electrical stimulation (NMES) protocols on swallowing function in patients with acute stroke-related dysphagia. The study compares traditional swallowing rehabilitation alone with three NMES-assisted intervention protocols to determine their impact on swallowing safety, efficiency, and rehabilitation outcomes. Ultrasonographic assessment of hyoid-laryngeal motion will be used as the primary instrumental outcome.
Detailed description
This randomized controlled, double-blind clinical trial aims to investigate the effects of different neuromuscular electrical stimulation (NMES) protocols-sensory, motor, and modified combined-on the swallowing function and suprahyoid muscle morphology in patients with acute hemiparetic stroke. Dysphagia is one of the most common and serious complications following stroke, leading to nutritional deficiencies, aspiration risk, and reduced quality of life. NMES has been increasingly used in dysphagia rehabilitation as a noninvasive technique that facilitates both peripheral muscle activation and central neuroplasticity.
A total of 40 acute hemiparetic stroke patients diagnosed with dysphagia will be recruited from the Acute Stroke Center of Istinye University Liv Hospital and randomly assigned to four groups:
Group 1: Sensory stimulation (submotor level, below contraction threshold) Group 2: Motor stimulation (supramotor level, visible contraction) Group 3: Modified combined stimulation (motor stimulation on the paretic side and sensory stimulation on the contralateral side) Group 4: Control group (conventional swallowing rehabilitation only) All intervention groups will receive NMES in addition to conventional dysphagia therapy for 10 sessions (40 minutes each). NMES parameters will be standardized as follows: channel mode co-contraction, frequency 80 Hz, pulse duration 180 μs, on-time 3 seconds, and off-time 20 seconds. Electrodes will be placed bilaterally, with the upper pair located above the hyoid bone and the lower pair over the thyrohyoid muscle.
The primary outcome measures will include ultrasonographic assessment of the suprahyoid muscles (muscle thickness, cross-sectional area, echo intensity, and shear-wave elasticity) and dynamic analysis of hyoid-laryngeal movement during swallowing of 5 mL boluses with standardized viscosity levels (IDDSI Level 0 and 4). Measurements will be performed using a LOGIQ P8 ultrasound system with B- and M-mode imaging according to Matsuo's hyoid-laryngeal motion index method.
The secondary outcome measures include videofluoroscopic swallowing study (VFSS) parameters such as the Penetration-Aspiration Scale (PAS), Bolus Residue Scale (BRS), and DIGEST scale, as well as clinical assessments like the Functional Oral Intake Scale (FOIS) and a Nurse Evaluation Form assessing perceived functional improvement via a visual analog scale.
Randomization will be computer-generated (randomizer.org), and all outcome assessments will be conducted by blinded evaluators. The intervention will be delivered by an experienced physiotherapist specialized in dysphagia management.
This study aims to provide comparative evidence on how different NMES stimulation types influence swallowing safety, efficiency, and muscle adaptation in acute stroke. By integrating instrumental (ultrasound and VFSS) and clinical outcomes, the findings will help identify the most effective NMES protocol and contribute to the development of individualized, evidence-based rehabilitation approaches for neurogenic dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four parallel groups. Each group will receive a different intervention protocol: sensory NMES, motor NMES, combined NMES, or control (traditional swallowing therapy only). Interventions will be applied independently to each group throughout the study period without crossover between groups. The study is designed to compare the effects of different NMES stimulation types on swallowing function in post-stroke patients with dysphagia.
| Arm | Type | Receives |
|---|---|---|
| Sensory NMES Group | Experimental | Device: Vitalstim-Sensory NMESParticipants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The stimulation is delivered at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. |
| Motor NMES Group | Experimental | Device: Vitalstim-Motor NMESParticipants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The stimulation is delivered at motor threshold with visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. |
| Combined NMES Group | Experimental | Device: Vitalstim-Combine NMESParticipants receive combined neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Motor-level NMES is applied to the hemiparetic side at motor threshold with visible muscle contraction, while sensory-level NMES is applied simultaneously to the contralateral (non-hemiparetic) side at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies. |
| Control Group | Active comparator | Behavioral: Conventional Swallowing TherapyParticipants receive conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional therapy includes traditional swallowing exercises and compensatory strategies administered by a therapist, such as effortful swallow, Mendelsohn maneuver, and tongue base exercises. Sessions last approximately 30 minutes for a total of 10 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years, Diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) within the past month, Modified Rankin Scale score ≤ 2, NIH Stroke Scale (NIHSS) score ≤ 25, Gugging Swallowing Screen (GUSS) score < 20, Ability to maintain upright sitting position during VFSS and therapy sessions, Voluntary participation with signed informed consent
Key exclusion criteria (1 listed)
- History of secondary stroke, Inability to follow simple verbal commands Unstable medical condition, History of head or neck cancer, neoplastic tissue growth, or epileptic seizures, Presence of musculoskeletal disorders affecting the neck or swallowing muscles, Cognitive impairment indicated by an IQCODE score > 3.4, Any neurological disease other than stroke that may cause swallowing disorders
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 |
|---|---|---|
| Conventional Swallowing TherapyParticipants receive only conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional swallowing therapy consists of structured swallowing exercises and compensatory strategies administered by a therapist, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. Sessions last approximately 30 minutes for a total of 10 sessions. | Behavioural | Control Group |
| Vitalstim-Sensory NMESParticipants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Stimulation is delivered at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. | Device | Sensory NMES Group |
| Vitalstim-Motor NMESParticipants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator, eliciting visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. | Device | Motor NMES Group |
| Vitalstim-Combine NMESParticipants receive combined neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Motor-level NMES is applied to the hemiparetic side, while sensory-level NMES is applied to the contralateral side within the same session. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. | Device | Combined NMES Group |
Primary outcome
Change in Suprahyoid Muscle Thickness
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Suprahyoid muscle thickness will be quantitatively measured using B-mode ultrasonography (LOGIQ P8, GE Healthcare). Measurements will be obtained at standardized anatomical landmarks by a trained examiner while participants are in a supine position with the head in neutral alignment. Thickness values will be recorded in millimeters and averaged over repeated measurements to assess morphological changes following the intervention.
Change in Suprahyoid Muscle Cross-Sectional Area
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
The cross-sectional area of the suprahyoid muscle group will be assessed using B-mode ultrasonography. Images will be captured in the transverse plane, and cross-sectional area will be calculated using image analysis software. This outcome reflects structural adaptations of the swallowing-related musculature in response to different NMES protocols.
Change in Suprahyoid Muscle Echogenicity
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Muscle echogenicity will be evaluated through grayscale analysis of B-mode ultrasound images. Mean grayscale values will be calculated to reflect muscle quality, with higher echogenicity indicating increased intramuscular connective or fatty tissue. Changes in echogenicity will be used as an indicator of muscle composition and structural integrity.
Change in Suprahyoid Muscle Stiffness
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Muscle stiffness will be assessed using shear wave elastography (SWE). Quantitative stiffness values (expressed in kilopascals) will be obtained from the suprahyoid muscle region during rest. SWE measurements provide information on the mechanical properties of muscle tissue and potential neuromuscular adaptations following NMES.
Change in Penetration-Aspiration Scale (PAS) Score
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Swallowing safety will be evaluated using Videofluoroscopic Swallowing Study (VFSS) performed by an experienced clinician according to standardized protocols. Participants will swallow standardized bolus volumes and consistencies based on the International Dysphagia Diet Standardisation Initiative (IDDSI) framework. VFSS recordings will be analyzed frame-by-frame, and airway invasion severity will be rated using the Penetration-Aspiration Scale (PAS), which ranges from 1 (no airway entry) to 8 (silent aspiration). PAS scores will be used to quantify changes in airway protection following the intervention.
Change in Bolus Residue Scale (BRS) Score
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Pharyngeal residue severity will be assessed during VFSS using the Bolus Residue Scale (BRS). VFSS examinations will include multiple swallows of standardized boluses across different IDDSI consistencies. Post-swallow residue will be evaluated in predefined anatomical regions and scored according to the BRS criteria to quantify bolus clearance efficiency and residue severity.
Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Overall swallowing function will be assessed using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) during VFSS. DIGEST scoring integrates VFSS-derived measures of airway invasion (PAS) and pharyngeal residue severity to provide a global classification of swallowing safety and efficiency. VFSS recordings will be reviewed by trained raters using standardized criteria.
2 secondary outcomes
Changes in Functional Oral Intake Scale (FOIS)
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
Changes in Nurse Observation Form for Swallowing Function
Time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
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 3 Mar 2026.
- Results publication: PubMed 18437464Bulow M, Speyer R, Baijens L, Woisard V, Ekberg O. Neuromuscular electrical stimulation (NMES) in stroke patients with oral and pharyngeal dysfunction. Dysphagia. 2008 Sep;23(3):302-9. doi: 10.1007/s00455-007-9145-9. Epub 2008 Apr 25.
- Results publication: PubMed 35743906Doan TN, Ho WC, Wang LH, Chang FC, Tran TTQ, Chou LW. Therapeutic Effect and Optimal Electrode Placement of Transcutaneous Neuromuscular Electrical Stimulation in Patients with Post-Stroke Dysphagia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Life (Basel). 2022 Jun 10;12(6):875. doi: 10.3390/life12060875.
- Results publication: PubMed 11309186Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
- Results publication: PubMed 27271373Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7.
- Results publication: PubMed 36127447Howard MM, Block ES, Mishreki D, Kim T, Rosario ER. The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients with Dysphagia: A Randomized Trial. Dysphagia. 2023 Jun;38(3):943-953. doi: 10.1007/s00455-022-10520-7. Epub 2022 Sep 20.
- Results publication: PubMed 39152545Ichikawa Y, Kikutani T, Sumi M, Iwata H, Takahashi N, Tohara T, Ozeki M, Tamura F. Intramuscular condition of swallowing-related muscles using shear-wave elastography: A preliminary study in healthy adults. J Oral Rehabil. 2024 Nov;51(11):2405-2414. doi: 10.1111/joor.13844. Epub 2024 Aug 16.
- Results publication: PubMed 19229451Lim KB, Lee HJ, Lim SS, Choi YI. Neuromuscular electrical and thermal-tactile stimulation for dysphagia caused by stroke: a randomized controlled trial. J Rehabil Med. 2009 Feb;41(3):174-8. doi: 10.2340/16501977-0317.
- Results publication: PubMed 25379488Lim KB, Lee HJ, Yoo J, Kwon YG. Effect of Low-Frequency rTMS and NMES on Subacute Unilateral Hemispheric Stroke With Dysphagia. Ann Rehabil Med. 2014 Oct;38(5):592-602. doi: 10.5535/arm.2014.38.5.592. Epub 2014 Oct 30.
- Results publication: PubMed 33730038Matsuo T, Matsuyama M. Detection of poststroke oropharyngeal dysphagia with swallowing screening by ultrasonography. PLoS One. 2021 Mar 17;16(3):e0248770. doi: 10.1371/journal.pone.0248770. eCollection 2021.
- Results publication: PubMed 22239880Mayans D, Cartwright MS, Walker FO. Neuromuscular ultrasonography: quantifying muscle and nerve measurements. Phys Med Rehabil Clin N Am. 2012 Feb;23(1):133-48, xii. doi: 10.1016/j.pmr.2011.11.009. Epub 2011 Dec 9.
- Results publication: PubMed 29278871Meng P, Zhang S, Wang Q, Wang P, Han C, Gao J, Yue S. The effect of surface neuromuscular electrical stimulation on patients with post-stroke dysphagia. J Back Musculoskelet Rehabil. 2018;31(2):363-370. doi: 10.3233/BMR-170788.
- Results publication: PubMed 19253803Permsirivanich W, Tipchatyotin S, Wongchai M, Leelamanit V, Setthawatcharawanich S, Sathirapanya P, Phabphal K, Juntawises U, Boonmeeprakob A. Comparing the effects of rehabilitation swallowing therapy vs. neuromuscular electrical stimulation therapy among stroke patients with persistent pharyngeal dysphagia: a randomized controlled study. J Med Assoc Thai. 2009 Feb;92(2):259-65.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request and approval from the principal investigator and relevant ethics committee.
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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.
Rabia KUM GÜLER, PhD(c), PT study director
Istanbul Arel U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Swallowing Therapy, Vitalstim-Sensory NMES and Vitalstim-Motor NMES in people with Dysphagia and Stroke, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 3 Mar 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 Turkey (Türkiye). 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?
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?
Change in Suprahyoid Muscle Thickness (time frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445204, which also lists 18 linked publications.
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 3 Mar 2026.