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

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.

Conditions

• Stroke
• Swallowing Disorders
• Dysphagia

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

Active Transcranial Magnetic Stimulation

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

OTHER

Conventional Swallowing Rehabilitations

All patients included this rehabilitation programs.

Sponsors & Collaborators

• Istinye University

  collaborator OTHER

• Atlas University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-02

Primary Completion

2026-12-29

Completion

2027-01-29

Countries

• Turkey (Türkiye)

Study Locations