NCT07793799

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
4mo left

Started May 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2024Jan 2027

Study Start

First participant enrolled

May 2, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

2.7 years

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

StrokeSwallowing DisordersDysphagia

Keywords

Post-Stroke DysphagiaNeuromuscular Electrical StimulationTranscranial Direct Current StimulationTranscranial Magnetic StimulationNon-invasive Brain StimulationStroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and immediately after completion of 10 treatment sessions

Secondary Outcomes (3)

  • Change in Bolus Residue Scale Score

    Baseline and immediately after completion of 10 treatment sessions

  • Functional Oral Intake Scale

    Baseline and immediately after completion of 10 treatment sessions

  • Change in Toronto Bedside Swallowing Screening Test Result

    Baseline and immediately after completion of 10 treatment sessions

Study Arms (4)

NMES Plus Sham tDCS

SHAM COMPARATOR

Participants receive neuromuscular electrical stimulation (NMES) combined with sham transcranial direct current stimulation (tDCS) for 10 treatment sessions.

Device: Neuromuscular Electrical StimulationDevice: Sham Transcranial Direct Current StimulationOther: Conventional Swallowing Rehabilitations

NMES Plus Sham TMS

SHAM COMPARATOR

Participants receive neuromuscular electrical stimulation (NMES) combined with sham transcranial magnetic stimulation (TMS) for 10 treatment sessions.

Device: Neuromuscular Electrical StimulationDevice: Sham Transcranial Magnetic StimulationOther: Conventional Swallowing Rehabilitations

Active tDCS Plus NMES

EXPERIMENTAL

Participants receive active transcranial direct current stimulation (tDCS) combined with neuromuscular electrical stimulation (NMES) for 10 treatment sessions.

Device: Neuromuscular Electrical StimulationDevice: Active Transcranial Direct Current StimulationOther: Conventional Swallowing Rehabilitations

Active TMS Plus NMES

EXPERIMENTAL

Participants receive active transcranial magnetic stimulation (TMS) combined with neuromuscular electrical stimulation (NMES) for 10 treatment sessions.

Device: Neuromuscular Electrical StimulationDevice: Active Transcranial Magnetic StimulationOther: Conventional Swallowing Rehabilitations

Interventions

Neuromuscular Electrical StimulationDEVICE

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

Active TMS Plus NMESActive tDCS Plus NMESNMES Plus Sham TMSNMES Plus Sham tDCS
Sham Transcranial Direct Current StimulationDEVICE

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.

NMES Plus Sham tDCS
Sham Transcranial Magnetic StimulationDEVICE

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.

NMES Plus Sham TMS
Active Transcranial Direct Current StimulationDEVICE

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

Active tDCS Plus NMES
Active Transcranial Magnetic StimulationDEVICE

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

Active TMS Plus NMES
Conventional Swallowing RehabilitationsOTHER

All patients included this rehabilitation programs.

Active TMS Plus NMESActive tDCS Plus NMESNMES Plus Sham TMSNMES Plus Sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Bahçeşehir Liv Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Bengisu S, Demir N, Krespi Y. Effectiveness of Conventional Dysphagia Therapy (CDT), Neuromuscular Electrical Stimulation (NMES), and Transcranial Direct Current Stimulation (tDCS) in Acute Post-Stroke Dysphagia: A Comparative Evaluation. Dysphagia. 2024 Feb;39(1):77-91. doi: 10.1007/s00455-023-10595-w. Epub 2023 May 29.

    PMID: 37247074RESULT

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Speech and Language Therapy

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

May 2, 2024

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

January 29, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because the informed consent and ethics approval do not include public sharing of individual-level data. Study findings will be reported in aggregate form to protect participant privacy and confidentiality.

Locations

TU(1)