Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Muscles and Swallowing Function in Acute Hemiparetic Stroke Patients

NCT07445204 | Enrolling By Invitation DMC

• 1 other identifier: IstanbulArelU-ETK-2025/47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysphagia; Stroke; Hemiparesis

Keywords

Dysphagia; Stroke; Neuromuscular Electrical Stimulation (NMES); Ultrasound Evaluation; Videofluoroscopic Swallow Study (VFSS); Swallowing Rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Secondary Outcomes (2)

• Changes in Functional Oral Intake Scale (FOIS)

  Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

• Changes in Nurse Observation Form for Swallowing Function

  Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Study Arms (4)

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.

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.

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.

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.

Behavioral: Conventional Swallowing Therapy

Interventions

Conventional Swallowing Therapy BEHAVIORAL

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.

Control Group

Vitalstim-Sensory NMES DEVICE

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.

Sensory NMES Group

Vitalstim-Motor NMES DEVICE

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.

Motor NMES Group

Vitalstim-Combine NMES DEVICE

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.

Combined NMES Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Arel University: lead
• Istinye University: collaborator
• Hacettepe University: collaborator

Study Sites (1)

İstinye University Hospital, Acute Stroke Center

Istanbul, Turkey (Türkiye)

Location

Related Publications (18)

• 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.

  PMID: 18437464 RESULT

• Doan 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.

  PMID: 35743906 RESULT

• Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.

  PMID: 11309186 RESULT

• Guillen-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.

  PMID: 27271373 RESULT

• Howard 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.

  PMID: 36127447 RESULT

• Ichikawa 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.

  PMID: 39152545 RESULT

• Lim 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.

  PMID: 19229451 RESULT

• • Lim, K. B., Lee, H. J., Yoo, J., Kwon, Y. G. 2014. "Effect of Low-Frequency rTMS and NMES on Subacute Unilateral Hemispheric Stroke With Dysphagia", Ann Rehabil Med, 38(5), 592-602.

  RESULT

• Matsuo 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.

  PMID: 33730038 RESULT

• Mayans 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.

  PMID: 22239880 RESULT

• • Meng, P., Zhang, S., Wang, Q., Wang, P., Han, C., Gao, J., Yue, S. 2018. "The effect of surface neuromuscular electrical stimulation on patients with post-stroke dysphagia", J Back Musculoskelet Rehabil, 31(2), 363-70.

  RESULT

• Permsirivanich 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.

  PMID: 19253803 RESULT

• Simonelli 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.

  PMID: 30714980 RESULT

• Taljanovic 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.

  PMID: 28493799 RESULT

• Umay 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.

  PMID: 28681742 RESULT

• • Zeng, Y., Yip, J., Cui, H., Guan, L., Zhu, H., Zhang, W., . . . Geng, X. 2018. "Efficacy of neuromuscular electrical stimulation in improving the negative psychological state in patients with cerebral infarction and dysphagia", Neurol Res, 40(6), 473-9.

  RESULT

• Zhang M, Tao T, Zhang ZB, Zhu X, Fan WG, Pu LJ, Chu L, Yue SW. Effectiveness of Neuromuscular Electrical Stimulation on Patients With Dysphagia With Medullary Infarction. Arch Phys Med Rehabil. 2016 Mar;97(3):355-62. doi: 10.1016/j.apmr.2015.10.104. Epub 2015 Nov 19.

  PMID: 26606872 RESULT

• • Zhao, J.-w., Wang, Z.-y., Cao, W.-z., Zhang, Y.-w., SONG, S.-c., Kang, W.-g., YANG, J.-h. 2015. "Therapeutic efficacy of swallowing neuromuscular electrical stimulation combined with acupuncture for post-stroke dysphagia", World Journal of Acupuncture-Moxibustion, 25(1), 19-23.

  RESULT

MeSH Terms

Conditions

Deglutition Disorders; Stroke; Paresis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabia KUM GÜLER, PhD(c), PT

  Istanbul Arel U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind. Both participants and outcome assessors are blinded to group allocation. Participants are unaware of whether they receive sensory, motor, combined NMES, or control intervention, as all sessions are conducted using identical equipment and electrode placement. Outcome assessors who analyze VFSS data are also blinded to the intervention groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 3, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)