StrokeNCT07793799
Comparison of NMES, tDCS, and TMS Treatments in Post-Stroke Dysphagia
A study testing Neuromuscular Electrical Stimulation, Active Transcranial Direct Current Stimulation and Active Transcranial Magnetic Stimulation in people with Stroke and Swallowing Disorders, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Swallowing Disorders, Dysphagia
- What is being tested?
- Neuromuscular Electrical Stimulation, Active Transcranial Direct Current Stimulation and Active Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effects of NMES, tDCS, and TMS Added to Conventional Dysphagia Therapy in Acute Post-Stroke Dysphagia: A Randomized Controlled Trial
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
- Being tested
- Neuromuscular Electrical Stimulation, Sham Transcranial Direct Current Stimulation, Sham Transcranial Magnetic Stimulation, Active Transcranial Direct Current Stimulation, Active Transcranial Magnetic Stimulation
- Keywords
- Post-Stroke Dysphagia, Neuromuscular Electrical Stimulation, Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation, Non-invasive Brain Stimulation, Stroke Rehabilitation
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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 Transcranial Magnetic StimulationDevice
Active transcranial magnetic stimulation is administered using a MagVenture neurostimulator and is combined with NMES for 10 treatment sessions.
Conventional Swallowing RehabilitationsOther
All patients included this rehabilitation programs.
| Study group | Role | What they receive |
|---|---|---|
| NMES Plus Sham tDCS | Sham comparator | Participants receive neuromuscular electrical stimulation (NMES) combined with sham transcranial direct current stimulation (tDCS) for 10 treatment sessions. Receives: Device: Neuromuscular Electrical Stimulation; Device: Sham Transcranial Direct Current Stimulation; Other: 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. Receives: Device: Neuromuscular Electrical Stimulation; Device: Sham Transcranial Magnetic Stimulation; Other: 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. Receives: Device: Neuromuscular Electrical Stimulation; Device: Active Transcranial Direct Current Stimulation; Other: 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. Receives: Device: Neuromuscular Electrical Stimulation; Device: Active Transcranial Magnetic Stimulation; Other: Conventional Swallowing Rehabilitations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after completion of 10 treatment sessions
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after completion of 10 treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start2 May 2024
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University
- Responsible party
- Principal investigator, Serkan Bengisu, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793799
- Sponsor's protocol ID
- AtlasU-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37247074
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of NMES, tDCS, and TMS Added to Conventional Dysphagia Therapy in Acute Post-Stroke Dysphagia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07793799
- Acronym / sponsor ID
- AtlasU-01
- Conditions
- Stroke, Swallowing Disorders, Dysphagia
- Keywords
- Post-Stroke Dysphagia, Neuromuscular Electrical Stimulation, Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation, Non-invasive Brain Stimulation, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Collaborators
- Istinye University
- Study start
- 2 May 2024 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| NMES Plus Sham tDCS | Sham comparator | Device: Neuromuscular Electrical Stimulation, Device: Sham Transcranial Direct Current Stimulation, Other: Conventional Swallowing RehabilitationsParticipants receive neuromuscular electrical stimulation (NMES) combined with sham transcranial direct current stimulation (tDCS) for 10 treatment sessions. |
| NMES Plus Sham TMS | Sham comparator | Device: Neuromuscular Electrical Stimulation, Device: Sham Transcranial Magnetic Stimulation, Other: Conventional Swallowing RehabilitationsParticipants receive neuromuscular electrical stimulation (NMES) combined with sham transcranial magnetic stimulation (TMS) for 10 treatment sessions. |
| Active tDCS Plus NMES | Experimental | Device: Neuromuscular Electrical Stimulation, Device: Active Transcranial Direct Current Stimulation, Other: Conventional Swallowing RehabilitationsParticipants receive active transcranial direct current stimulation (tDCS) combined with neuromuscular electrical stimulation (NMES) for 10 treatment sessions. |
| Active TMS Plus NMES | Experimental | Device: Neuromuscular Electrical Stimulation, Device: Active Transcranial Magnetic Stimulation, Other: Conventional Swallowing RehabilitationsParticipants receive active transcranial magnetic stimulation (TMS) combined with neuromuscular electrical stimulation (NMES) for 10 treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulationNeuromuscular electrical stimulation is applied using the VitalStim device as part of the dysphagia rehabilitation program. Participants receive NMES during 10 treatment sessions. | Device | Active TMS Plus NMES, Active tDCS Plus NMES, NMES Plus Sham TMS, NMES Plus Sham tDCS |
| Sham Transcranial Direct Current StimulationSham 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 | NMES Plus Sham tDCS |
| Sham Transcranial Magnetic StimulationSham 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 | NMES Plus Sham TMS |
| Active Transcranial Direct Current StimulationActive transcranial direct current stimulation is administered using the neuroConn DC-Stimulator and is combined with NMES for 10 treatment sessions. | Device | Active tDCS Plus NMES |
| Active Transcranial Magnetic StimulationActive transcranial magnetic stimulation is administered using a MagVenture neurostimulator and is combined with NMES for 10 treatment sessions. | Device | Active TMS Plus NMES |
| Conventional Swallowing RehabilitationsAll patients included this rehabilitation programs. | Other | Active TMS Plus NMES, Active tDCS Plus NMES, NMES Plus Sham TMS, NMES Plus Sham tDCS |
Primary outcome
Change in Penetration-Aspiration Scale Score for Liquid Boluses
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Bolus Residue Scale Score
Time frame: Baseline and immediately after completion of 10 treatment sessions
Functional Oral Intake Scale
Time frame: Baseline and immediately after completion of 10 treatment sessions
Change in Toronto Bedside Swallowing Screening Test Result
Time frame: Baseline and immediately after completion of 10 treatment sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 37247074Bengisu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation, Active Transcranial Direct Current Stimulation and Active Transcranial Magnetic Stimulation in people with Stroke and Swallowing Disorders, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penetration-Aspiration Scale Score for Liquid Boluses (time frame: Baseline and immediately after completion of 10 treatment sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07793799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.