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Comparison of NMES, tDCS, and TMS Treatments in Post-Stroke Dysphagia
Sponsor: Atlas University
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.
Official title: Comparative Effects of NMES, tDCS, and TMS Added to Conventional Dysphagia Therapy in Acute Post-Stroke Dysphagia: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-05-02
Completion Date
2027-01-29
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Neuromuscular 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.
Sham 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.
Sham 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.
Active 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
Active transcranial magnetic stimulation is administered using a MagVenture neurostimulator and is combined with NMES for 10 treatment sessions.
Conventional Swallowing Rehabilitations
All patients included this rehabilitation programs.
Locations (1)
Istinye Bahçeşehir Liv Hospital
Istanbul, Turkey (Türkiye)