Stroke, ComplicationNCT07152899
Innovative Treatments for Neurogenic Dysphagia
A study testing Unilateral anodal tDCS, Bihemispheric anodal tDCS and NMES + swallowing therapy in people with Stroke, Complication and Parkinson's Disease, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
This study aims to evaluate different non-invasive and neuromuscular stimulation treatments for neurogenic dysphagia in post-stroke and Parkinson's disease patients. The study is divided into three sub-studies: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Complication, Parkinson's Disease
- What is being tested?
- Unilateral anodal tDCS, Bihemispheric anodal tDCS and NMES + swallowing therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-85 years
- Diagnosis of post-stroke or Parkinson's disease-related dysphagia
- Dysphagia duration ≥ 2 weeks for post-stroke patients and ≥ 6 months for Parkinson's disease patients
- Ability to undergo rehabilitation therapy
- Written informed consent obtained
Who cannot join
- Severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) feeding for more than 1 year
- Non-neurogenic causes of dysphagia
- Contraindications to tDCS or NMES
- Cognitive impairment affecting compliance with treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approaches for the Treatment of Post-stroke Dysphagia and Dysphagia in Parkinson's Disease
This study aims to evaluate different non-invasive and neuromuscular stimulation treatments for neurogenic dysphagia in post-stroke and Parkinson's disease patients. The study is divided into three sub-studies:
- Unilateral, bihemispheric, or sham transcranial Direct Current Stimulation (tDCS) in post-stroke dysphagia (patients ≥2 weeks from onset).
- Bihemispheric or sham tDCS in Parkinson's disease-related dysphagia.
- Neuromuscular stimulation therapy in post-stroke and Parkinson's disease dysphagia.
Read the detailed description
Neurogenic dysphagia, commonly seen in post-stroke and Parkinson's disease patients, significantly impacts quality of life. Despite emerging treatments, there remains a lack of consensus on the best approaches for these conditions. This study evaluates three different innovative therapeutic interventions and their efficacy in improving swallowing function:
Sub-study 1: Evaluates the effects of unilateral, bihemispheric, or sham tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia.
Sub-study 2: Evaluates the effects of bihemispheric or sham tDCS in Parkinson's disease patients with dysphagia.
Sub-study 3: Examines the effects of neuromuscular electrical stimulation (NMES) therapy on swallowing function in both post-stroke and Parkinson's disease patients.
Each intervention was administered over a 6-week period with outcome measures assessed at baseline and post-treatment. All treatments were applied in conjunction with a personalized and intensive speech therapy program.
This study aims to provide valuable insights into the effectiveness of tDCS and NMES as adjuncts to traditional swallowing therapy. By targeting mechanisms of brain plasticity and neuromuscular function, the study could improve treatment strategies for neurogenic dysphagia in stroke and Parkinson's disease patients. Ultimately, the findings could contribute to evidence-based guidelines for managing dysphagia in these populations.
This interventional study recruited a total of 110 participants: 70 patients with post-stroke dysphagia and 40 patients with Parkinson's disease-related dysphagia. Participants were consecutively enrolled from collaborating institutions.
Following informed consent, participants underwent a standardized evaluation protocol consisting of clinical and neurophysiological assessments. Swallowing function was assessed using the Dysphagia Outcome and Severity Scale (DOSS) as the primary outcome measure. Secondary outcomes include the Penetration-Aspiration Scale (PAS), Mann Assessment of Swallowing Ability (MASA), Swallowing Quality of Life Questionnaire (SWAL-QOL), and Motor Evoked Potentials (MEPs) of tongue musculature in a subgroup of participants.
All stimulation interventions (tDCS or NMES) were delivered by trained clinicians according to standardized protocols. Each session was accompanied by a personalized intensive speech and swallowing therapy session, administered by certified speech-language pathologists.
- Conditions
- Stroke, Complication, Parkinson's Disease
- Being tested
- Unilateral anodal tDCS, Bihemispheric anodal tDCS, Sham tDCS, NMES + swallowing therapy, Sham NMES + swallowing therapy
- Keywords
- Dysphagia, Stroke, Parkinson's Disease, Transcranial Direct Current Stimulation (tDCS), Neuromuscular Electrical Stimulation (NMES), Swallowing Therapy
- Medical subject headings
- Stroke, Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral anodal tDCSOther
Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia
Bihemispheric anodal tDCSOther
Evaluates the effects of bihemispheric, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia and in Parkinson's disease-related dysphagia
Sham tDCSOther
Evaluates the effects of Sham tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia and in Parkinson's disease-related dysphagia
NMES + swallowing therapyOther
Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients
Sham NMES + swallowing therapyOther
Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients
| Study group | Role | What they receive |
|---|---|---|
| Unilateral anodal tDCS | Experimental | In post-stroke dysphagia Receives: Other: Unilateral anodal tDCS |
| Bihemispheric anodal tDCS | Experimental | In post-stroke dysphagia Receives: Other: Bihemispheric anodal tDCS |
| Sham tDCS | Placebo comparator | In post-stroke dysphagia Receives: Other: Sham tDCS |
| Anodal tDCS in both hemispheres | Experimental | In Parkinson's disease dysphagia Receives: Other: Bihemispheric anodal tDCS |
| Placebo tDCS | Placebo comparator | In Parkinson's disease dysphagia Receives: Other: Sham tDCS |
| NMES + swallowing therapy | Experimental | In patients with post-stroke dysphagia and Parkinson's disease dysphagia Receives: Other: NMES + swallowing therapy |
| Sham NMES + swallowing therapy | Placebo comparator | In patients with post-stroke dysphagia and Parkinson's disease dysphagia Receives: Other: Sham NMES + swallowing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Outcome and Severity Scale (DOSS) score
Improvement in DOSS.The DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition.
Measured: At baseline and 6 weeks post-treatment
Secondary outcomes (4)
Penetration-Aspiration Scale (PAS) score
Changes in PAS. It's a 8-point scale to score the degree of airway invasion and patient response.
Measured: At baseline and 6 weeks post-treatment
Mann Assessment of Swallowing Ability (MASA) score
Clinical evaluation using the MASA. The MASA is an instrument that was designed for bedside evaluations for patients referred for swallowing function assessment.
This assessment measures 24 different areas to gauge a patient's swallowing ability, in order to make appropriate recommendations for diet and fluid intake.
Measured: At baseline and 6 weeks post-treatment
Swallowing Quality of Life (SWAL-QOL) questionnaire
The SWAL-QOL questionnaire was constructed for use in clinical research for patients with oropharyngeal dysphagia.
Measured: At baseline and 6 weeks post-treatment
Motor Evoked Potentials (MEP) assessment
Motor Evoked Potentials (MEP) assessment of tongue muscle response in a small patients subgroup .
Measured: At baseline and 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Jun 2021
- Primary completion15 Jan 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Stroke, ComplicationStudies 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
- Following informed consent, participants underwent a standardized evaluation protocol consisting of clinical and neurophysiological assessments. Swallowing function was assessed using the Dysphagia Outcome and Severity Scale (DOSS) as the primary outcome measure. Secondary outcomes include the Penetration-Aspiration Scale (PAS), Mann Assessment of Swallowing Ability (MASA), Swallowing Quality of Life Questionnaire (SWAL-QOL), and Motor Evoked Potentials (MEPs) of tongue musculature in a subgroup of participants. All stimulation interventions (tDCS or NMES) were delivered by trained clinicians according to standardized protocols. Each session was accompanied by a personalized intensive speech and swallowing therapy session, administered by certified speech-language pathologists.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo, L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy, Fondazione Don Carlo Gnocchi ETS, Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Sponsor
- Investigators
- Giuseppe Cosentino, MD, Principal investigator, Translational Neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152899
- Sponsor's protocol ID
- Neu-Dysphagia
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn YH, Sohn HJ, Park JS, Ahn TG, Shin YB, Park M, Ko SH, Shin YI. Effect of bihemispheric anodal transcranial direct current stimulation for dysphagia in chronic stroke patients: A randomized clinical trial. J Rehabil Med. 2017 Jan 19;49(1):30-35. doi: 10.2340/16501977-2170.
PubMed 27904911Arnold M, Liesirova K, Broeg-Morvay A, Meisterernst J, Schlager M, Mono ML, El-Koussy M, Kagi G, Jung S, Sarikaya H. Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome. PLoS One. 2016 Feb 10;11(2):e0148424. doi: 10.1371/journal.pone.0148424. eCollection 2016.
PubMed 26863627Frost J, Robinson HF, Hibberd J. A comparison of neuromuscular electrical stimulation and traditional therapy, versus traditional therapy in patients with longstanding dysphagia. Curr Opin Otolaryngol Head Neck Surg. 2018 Jun;26(3):167-173. doi: 10.1097/MOO.0000000000000454.
PubMed 29553959Geeganage C, Beavan J, Ellender S, Bath PM. Interventions for dysphagia and nutritional support in acute and subacute stroke. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000323. doi: 10.1002/14651858.CD000323.pub2.
PubMed 23076886Ginocchio D, Alfonsi E, Mozzanica F, Accornero AR, Bergonzoni A, Chiarello G, De Luca N, Farneti D, Marilia S, Calcagno P, Turroni V, Schindler A. Cross-Cultural Adaptation and Validation of the Italian Version of SWAL-QOL. Dysphagia. 2016 Oct;31(5):626-34. doi: 10.1007/s00455-016-9720-z. Epub 2016 Jul 21.
PubMed 27444734O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 1999 Summer;14(3):139-45. doi: 10.1007/PL00009595.
PubMed 10341109Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24.
PubMed 21441148Langmore SE, Pisegna JM. Efficacy of exercises to rehabilitate dysphagia: A critique of the literature. Int J Speech Lang Pathol. 2015 Jun;17(3):222-9. doi: 10.3109/17549507.2015.1024171. Epub 2015 Mar 31.
PubMed 25825989Liang Y, Lin J, Wang H, Li S, Chen F, Chen L, Li L. Evaluating the Efficacy of VitalStim Electrical Stimulation Combined with Swallowing Function Training for Treating Dysphagia following an Acute Stroke. Clinics (Sao Paulo). 2021 Nov 8;76:e3069. doi: 10.6061/clinics/2021/e3069. eCollection 2021.
PubMed 34755758Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke. 1999 Apr;30(4):744-8. doi: 10.1161/01.str.30.4.744.
PubMed 10187872Robbins J, Butler SG, Daniels SK, Diez Gross R, Langmore S, Lazarus CL, Martin-Harris B, McCabe D, Musson N, Rosenbek J. Swallowing and dysphagia rehabilitation: translating principles of neural plasticity into clinically oriented evidence. J Speech Lang Hear Res. 2008 Feb;51(1):S276-300. doi: 10.1044/1092-4388(2008/021).
PubMed 18230851Shigematsu T, Fujishima I, Ohno K. Transcranial direct current stimulation improves swallowing function in stroke patients. Neurorehabil Neural Repair. 2013 May;27(4):363-9. doi: 10.1177/1545968312474116. Epub 2013 Feb 7.
PubMed 23392916Speyer R, Baijens L, Heijnen M, Zwijnenberg I. Effects of therapy in oropharyngeal dysphagia by speech and language therapists: a systematic review. Dysphagia. 2010 Mar;25(1):40-65. doi: 10.1007/s00455-009-9239-7. Epub 2009 Sep 17.
PubMed 19760458Suntrup-Krueger S, Ringmaier C, Muhle P, Wollbrink A, Kemmling A, Hanning U, Claus I, Warnecke T, Teismann I, Pantev C, Dziewas R. Randomized trial of transcranial direct current stimulation for poststroke dysphagia. Ann Neurol. 2018 Feb;83(2):328-340. doi: 10.1002/ana.25151. Epub 2018 Feb 6.
PubMed 29350775Yang EJ, Baek SR, Shin J, Lim JY, Jang HJ, Kim YK, Paik NJ. Effects of transcranial direct current stimulation (tDCS) on post-stroke dysphagia. Restor Neurol Neurosci. 2012;30(4):303-11. doi: 10.3233/RNN-2012-110213.
PubMed 22572022
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches for the Treatment of Post-stroke Dysphagia and Dysphagia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07152899
- Acronym / sponsor ID
- Neu-Dysphagia
- Conditions
- Stroke, Complication, Parkinson's Disease
- Keywords
- Dysphagia, Stroke, Parkinson's Disease, Transcranial Direct Current Stimulation (tDCS), Neuromuscular Electrical Stimulation (NMES), Swallowing Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo, L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy, Fondazione Don Carlo Gnocchi ETS, Istituti Clinici Scientifici Maugeri SpA
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 3 Sep 2025 (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 study aims to evaluate different non-invasive and neuromuscular stimulation treatments for neurogenic dysphagia in post-stroke and Parkinson's disease patients. The study is divided into three sub-studies:
- Unilateral, bihemispheric, or sham transcranial Direct Current Stimulation (tDCS) in post-stroke dysphagia (patients ≥2 weeks from onset).
- Bihemispheric or sham tDCS in Parkinson's disease-related dysphagia.
- Neuromuscular stimulation therapy in post-stroke and Parkinson's disease dysphagia.
Detailed description
Neurogenic dysphagia, commonly seen in post-stroke and Parkinson's disease patients, significantly impacts quality of life. Despite emerging treatments, there remains a lack of consensus on the best approaches for these conditions. This study evaluates three different innovative therapeutic interventions and their efficacy in improving swallowing function:
Sub-study 1: Evaluates the effects of unilateral, bihemispheric, or sham tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia.
Sub-study 2: Evaluates the effects of bihemispheric or sham tDCS in Parkinson's disease patients with dysphagia.
Sub-study 3: Examines the effects of neuromuscular electrical stimulation (NMES) therapy on swallowing function in both post-stroke and Parkinson's disease patients.
Each intervention was administered over a 6-week period with outcome measures assessed at baseline and post-treatment. All treatments were applied in conjunction with a personalized and intensive speech therapy program.
This study aims to provide valuable insights into the effectiveness of tDCS and NMES as adjuncts to traditional swallowing therapy. By targeting mechanisms of brain plasticity and neuromuscular function, the study could improve treatment strategies for neurogenic dysphagia in stroke and Parkinson's disease patients. Ultimately, the findings could contribute to evidence-based guidelines for managing dysphagia in these populations.
This interventional study recruited a total of 110 participants: 70 patients with post-stroke dysphagia and 40 patients with Parkinson's disease-related dysphagia. Participants were consecutively enrolled from collaborating institutions.
Following informed consent, participants underwent a standardized evaluation protocol consisting of clinical and neurophysiological assessments. Swallowing function was assessed using the Dysphagia Outcome and Severity Scale (DOSS) as the primary outcome measure. Secondary outcomes include the Penetration-Aspiration Scale (PAS), Mann Assessment of Swallowing Ability (MASA), Swallowing Quality of Life Questionnaire (SWAL-QOL), and Motor Evoked Potentials (MEPs) of tongue musculature in a subgroup of participants.
All stimulation interventions (tDCS or NMES) were delivered by trained clinicians according to standardized protocols. Each session was accompanied by a personalized intensive speech and swallowing therapy session, administered by certified speech-language pathologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Following informed consent, participants underwent a standardized evaluation protocol consisting of clinical and neurophysiological assessments. Swallowing function was assessed using the Dysphagia Outcome and Severity Scale (DOSS) as the primary outcome measure. Secondary outcomes include the Penetration-Aspiration Scale (PAS), Mann Assessment of Swallowing Ability (MASA), Swallowing Quality of Life Questionnaire (SWAL-QOL), and Motor Evoked Potentials (MEPs) of tongue musculature in a subgroup of participants. All stimulation interventions (tDCS or NMES) were delivered by trained clinicians according to standardized protocols. Each session was accompanied by a personalized intensive speech and swallowing therapy session, administered by certified speech-language pathologists.
| Arm | Type | Receives |
|---|---|---|
| Unilateral anodal tDCS | Experimental | Other: Unilateral anodal tDCSIn post-stroke dysphagia |
| Bihemispheric anodal tDCS | Experimental | Other: Bihemispheric anodal tDCSIn post-stroke dysphagia |
| Sham tDCS | Placebo comparator | Other: Sham tDCSIn post-stroke dysphagia |
| Anodal tDCS in both hemispheres | Experimental | Other: Bihemispheric anodal tDCSIn Parkinson's disease dysphagia |
| Placebo tDCS | Placebo comparator | Other: Sham tDCSIn Parkinson's disease dysphagia |
| NMES + swallowing therapy | Experimental | Other: NMES + swallowing therapyIn patients with post-stroke dysphagia and Parkinson's disease dysphagia |
| Sham NMES + swallowing therapy | Placebo comparator | Other: Sham NMES + swallowing therapyIn patients with post-stroke dysphagia and Parkinson's disease dysphagia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-85 years
- Diagnosis of post-stroke or Parkinson's disease-related dysphagia
- Dysphagia duration ≥ 2 weeks for post-stroke patients and ≥ 6 months for Parkinson's disease patients
- Ability to undergo rehabilitation therapy
- Written informed consent obtained
Key exclusion criteria (4 listed)
- Severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) feeding for more than 1 year
- Non-neurogenic causes of dysphagia
- Contraindications to tDCS or NMES
- Cognitive impairment affecting compliance with treatment
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 |
|---|---|---|
| Unilateral anodal tDCSEvaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia | Other | Unilateral anodal tDCS |
| Bihemispheric anodal tDCSEvaluates the effects of bihemispheric, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia and in Parkinson's disease-related dysphagia | Other | Anodal tDCS in both hemispheres, Bihemispheric anodal tDCS |
| Sham tDCSEvaluates the effects of Sham tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia and in Parkinson's disease-related dysphagia | Other | Placebo tDCS, Sham tDCS |
| NMES + swallowing therapyExamines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients | Other | NMES + swallowing therapy |
| Sham NMES + swallowing therapyExamines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients | Other | Sham NMES + swallowing therapy |
Primary outcome
Dysphagia Outcome and Severity Scale (DOSS) score
Time frame: At baseline and 6 weeks post-treatment
Improvement in DOSS.The DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition.
4 secondary outcomes
Penetration-Aspiration Scale (PAS) score
Time frame: At baseline and 6 weeks post-treatment
Mann Assessment of Swallowing Ability (MASA) score
Time frame: At baseline and 6 weeks post-treatment
Swallowing Quality of Life (SWAL-QOL) questionnaire
Time frame: At baseline and 6 weeks post-treatment
Motor Evoked Potentials (MEP) assessment
Time frame: At baseline and 6 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 27904911Ahn YH, Sohn HJ, Park JS, Ahn TG, Shin YB, Park M, Ko SH, Shin YI. Effect of bihemispheric anodal transcranial direct current stimulation for dysphagia in chronic stroke patients: A randomized clinical trial. J Rehabil Med. 2017 Jan 19;49(1):30-35. doi: 10.2340/16501977-2170.
- Background: PubMed 26863627Arnold M, Liesirova K, Broeg-Morvay A, Meisterernst J, Schlager M, Mono ML, El-Koussy M, Kagi G, Jung S, Sarikaya H. Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome. PLoS One. 2016 Feb 10;11(2):e0148424. doi: 10.1371/journal.pone.0148424. eCollection 2016.
- Background: PubMed 29553959Frost J, Robinson HF, Hibberd J. A comparison of neuromuscular electrical stimulation and traditional therapy, versus traditional therapy in patients with longstanding dysphagia. Curr Opin Otolaryngol Head Neck Surg. 2018 Jun;26(3):167-173. doi: 10.1097/MOO.0000000000000454.
- Background: PubMed 23076886Geeganage C, Beavan J, Ellender S, Bath PM. Interventions for dysphagia and nutritional support in acute and subacute stroke. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000323. doi: 10.1002/14651858.CD000323.pub2.
- Background: PubMed 27444734Ginocchio D, Alfonsi E, Mozzanica F, Accornero AR, Bergonzoni A, Chiarello G, De Luca N, Farneti D, Marilia S, Calcagno P, Turroni V, Schindler A. Cross-Cultural Adaptation and Validation of the Italian Version of SWAL-QOL. Dysphagia. 2016 Oct;31(5):626-34. doi: 10.1007/s00455-016-9720-z. Epub 2016 Jul 21.
- Background: PubMed 10341109O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 1999 Summer;14(3):139-45. doi: 10.1007/PL00009595.
- Background: PubMed 21441148Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24.
- Background: PubMed 25825989Langmore SE, Pisegna JM. Efficacy of exercises to rehabilitate dysphagia: A critique of the literature. Int J Speech Lang Pathol. 2015 Jun;17(3):222-9. doi: 10.3109/17549507.2015.1024171. Epub 2015 Mar 31.
- Background: PubMed 34755758Liang Y, Lin J, Wang H, Li S, Chen F, Chen L, Li L. Evaluating the Efficacy of VitalStim Electrical Stimulation Combined with Swallowing Function Training for Treating Dysphagia following an Acute Stroke. Clinics (Sao Paulo). 2021 Nov 8;76:e3069. doi: 10.6061/clinics/2021/e3069. eCollection 2021.
- Background: PubMed 10187872Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke. 1999 Apr;30(4):744-8. doi: 10.1161/01.str.30.4.744.
- Background: PubMed 18230851Robbins J, Butler SG, Daniels SK, Diez Gross R, Langmore S, Lazarus CL, Martin-Harris B, McCabe D, Musson N, Rosenbek J. Swallowing and dysphagia rehabilitation: translating principles of neural plasticity into clinically oriented evidence. J Speech Lang Hear Res. 2008 Feb;51(1):S276-300. doi: 10.1044/1092-4388(2008/021).
- Background: PubMed 23392916Shigematsu T, Fujishima I, Ohno K. Transcranial direct current stimulation improves swallowing function in stroke patients. Neurorehabil Neural Repair. 2013 May;27(4):363-9. doi: 10.1177/1545968312474116. Epub 2013 Feb 7.
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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. This study is not recruiting at the moment.
Giuseppe Cosentino, MD principal investigator
Translational Neurophysiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral anodal tDCS, Bihemispheric anodal tDCS and NMES + swallowing therapy in people with Stroke, Complication and Parkinson's Disease, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Sep 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dysphagia Outcome and Severity Scale (DOSS) score (time frame: At baseline and 6 weeks post-treatment). 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 NCT07152899, which also lists 15 linked publications.
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 3 Sep 2025.