Dysphagia, Stroke, Swallowing Disorders
Conditions
Keywords
Post-Stroke Dysphagia, Neuromuscular Electrical Stimulation, Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation, Non-invasive Brain Stimulation, Stroke Rehabilitation
Brief summary
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.
Interventions
DEVICENeuromuscular Electrical Stimulation
Neuromuscular electrical stimulation is applied using the VitalStim device as part of the dysphagia rehabilitation program. Participants receive NMES during 10 treatment sessions.
DEVICESham Transcranial Direct Current Stimulation
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.
DEVICESham Transcranial Magnetic Stimulation
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.
DEVICEActive Transcranial Direct Current Stimulation
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.
OTHERConventional Swallowing Rehabilitations
All patients included this rehabilitation programs.
Sponsors
Atlas University
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are unaware of their assigned intervention group. Sham tDCS or sham TMS is administered in the relevant control groups to maintain participant masking. The therapists administering the interventions are not masked because of the nature of the procedures.
Intervention model description
Participants will be randomly assigned to one of four parallel intervention groups, with 10 participants in each group: NMES plus sham tDCS, NMES plus sham TMS, active tDCS plus NMES, or active TMS plus NMES. Each participant will receive 10 treatment sessions according to the assigned intervention, with no crossover between groups. Outcomes will be assessed before and after the intervention period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penetration-Aspiration Scale Score for Liquid Boluses | 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. |
| Change in Dynamic Imaging Grade of Swallowing Toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Bolus Residue Scale Score | 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. |
| Functional Oral Intake Scale | 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. |
| Change in Toronto Bedside Swallowing Screening Test Result | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed