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OpenTrials
Enrolling by invitation

NCT Number: NCT07793799

Comparison of NMES, tDCS, and TMS Treatments in Post-Stroke Dysphagia

This randomized, single-blind, controlled clinical trial aims to compare the effectiveness of neuromuscular electrical stimulation (NMES) administered alone or in combination with transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS) in adults with post-stroke dysphagia.

A total of 40 participants will be randomly assigned to four parallel groups, with 10 participants in each group: NMES combined with sham tDCS, NMES combined with sham TMS, active tDCS combined with NMES, and active TMS combined with NMES. Each participant will receive 10 treatment sessions.

Swallowing function will be assessed before and after treatment using clinical swallowing assessments and videofluoroscopic swallowing examinations. Treatment effectiveness will be evaluated using the Toronto Bedside Swallowing Screening Test, Functional Oral Intake Scale, Penetration-Aspiration Scale, Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Bolus Residue Scale. The study seeks to determine whether combining central stimulation methods with NMES provides greater improvements in swallowing safety, dysphagia severity, pharyngeal residue, and oral intake than NMES-based control interventions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye Bahçeşehir Liv Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Diagnosis of ischemic or hemorrhagic stroke
  • Diagnosis of hemispheric stroke
  • Presence of swallowing difficulty or symptoms of dysphagia
  • Ability to cooperate and follow instructions
  • Absence of skin problems or abnormal tissue growth that would interfere with electrode placement

Exclusion criteria

  • Presence of typical neurological findings suggestive of brainstem stroke
  • Inadequate sitting balance or inability to maintain the head in an upright position, with or without support
  • Presence of a neoplastic disease in the head and neck region or a history of radiotherapy to this region
  • Presence of an additional musculoskeletal disorder that may cause swallowing impairment
  • Presence of a neurological disorder other than stroke that may cause swallowing impairment, including traumatic brain injury, Parkinson's disease, dementia, amyotrophic lateral sclerosis, or multiple sclerosis
  • Presence of a cardiac pacemaker, deep brain stimulator, or ear tube
  • History of epileptic seizures
  • Presence of a metallic implant in the body or skull

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

Neuromuscular electrical stimulation is applied using the VitalStim device as part of the dysphagia rehabilitation program. Participants receive NMES during 10 treatment sessions.

Sham Transcranial Direct Current Stimulation

Device

Sham tDCS is administered using the neuroConn DC-Stimulator to simulate the active procedure without delivering the full therapeutic stimulation protocol. It is combined with NMES for 10 treatment sessions.

Sham Transcranial Magnetic Stimulation

Device

Sham TMS is administered using a MagVenture neurostimulator to simulate the active procedure without delivering therapeutic magnetic stimulation. It is combined with NMES for 10 treatment sessions.

Active Transcranial Direct Current Stimulation

Device

Active transcranial direct current stimulation is administered using the neuroConn DC-Stimulator and is combined with NMES for 10 treatment sessions.

Active Transcranial Magnetic Stimulation

Device

Active transcranial magnetic stimulation is administered using a MagVenture neurostimulator and is combined with NMES for 10 treatment sessions.

Conventional Swallowing Rehabilitations

Other

All patients included this rehabilitation programs.

Primary outcomes

  1. Change in Penetration-Aspiration Scale Score for Liquid Boluses

    Time frame: Baseline and immediately after completion of 10 treatment sessions

    Swallowing safety for liquid boluses will be assessed from videofluoroscopic swallowing recordings using the 8-point Penetration-Aspiration Scale (PAS). Scores range from 1 to 8, with higher scores indicating greater airway invasion and more severe impairment. The change from baseline to post-treatment will be compared among the four intervention groups.

  2. Change in Dynamic Imaging Grade of Swallowing Toxicity

    Time frame: Baseline and immediately after completion of 10 treatment sessions

    The severity of pharyngeal dysphagia will be assessed from videofluoroscopic swallowing recordings using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST combines swallowing safety, based primarily on the Penetration-Aspiration Scale, and swallowing efficiency, based on pharyngeal residue, to generate an overall grade ranging from 0 to 4. Grade 0 indicates no pharyngeal dysphagia, while grades 1, 2, 3, and 4 indicate mild, moderate, severe, and life-threatening pharyngeal dysphagia, respectively. Lower scores represent better swallowing function. Change from baseline to post-treatment will be compared among the intervention groups.

Secondary outcomes

  1. Change in Bolus Residue Scale Score

    Time frame: Baseline and immediately after completion of 10 treatment sessions

    Pharyngeal residue will be assessed from videofluoroscopic swallowing recordings using the Bolus Residue Scale (BRS). The scale ranges from 1 to 6 according to the number and location of pharyngeal structures containing residue. A score of 1 indicates no residue, while higher scores indicate residue involving a greater number of pharyngeal structures and therefore worse bolus clearance. Change from baseline to post-treatment will be compared among the intervention groups.

  2. Functional Oral Intake Scale

    Time frame: Baseline and immediately after completion of 10 treatment sessions

    Functional oral intake will be evaluated using the Functional Oral Intake Scale (FOIS). The FOIS is a 7-level ordinal scale ranging from 1, indicating no oral intake, to 7, indicating a total oral diet with no restrictions. Higher scores represent greater functional oral intake and less dependence on tube feeding or dietary modification. Change from baseline to post-treatment will be compared among the intervention groups.

  3. Change in Toronto Bedside Swallowing Screening Test Result

    Time frame: Baseline and immediately after completion of 10 treatment sessions

    The presence of clinical signs associated with dysphagia will be evaluated using the Toronto Bedside Swallowing Screening Test (TOR-BSST). Each item is rated as pass or fail. Failure on any item results in an overall failed screening result and indicates an increased risk of dysphagia. The number and proportion of participants passing or failing the screening before and after treatment will be evaluated.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Collaborators

  • Istinye University

Registry information

Official study title

Comparative Effects of NMES, tDCS, and TMS Added to Conventional Dysphagia Therapy in Acute Post-Stroke Dysphagia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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