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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Neuromuscular electrical stimulation is applied using the VitalStim device as part of the dysphagia rehabilitation program. Participants receive NMES during 10 treatment sessions.
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 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 is administered using the neuroConn DC-Stimulator and is combined with NMES for 10 treatment sessions.
Active transcranial magnetic stimulation is administered using a MagVenture neurostimulator and is combined with NMES for 10 treatment sessions.
All patients included this rehabilitation programs.
Istinye Bahçeşehir Liv Hospital
Istanbul, Turkey (Türkiye)
Change in Penetration-Aspiration Scale Score for Liquid Boluses
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.
Time frame: Baseline and immediately after completion of 10 treatment sessions
Change in Dynamic Imaging Grade of Swallowing Toxicity
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.
Time frame: Baseline and immediately after completion of 10 treatment sessions
Change in Bolus Residue Scale Score
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.
Time frame: Baseline and immediately after completion of 10 treatment sessions
Functional Oral Intake Scale
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.
Time frame: Baseline and immediately after completion of 10 treatment sessions
Change in Toronto Bedside Swallowing Screening Test Result
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.
Time frame: Baseline and immediately after completion of 10 treatment sessions
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