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| Name | Class |
|---|---|
| ASST Santi Paolo e Carlo | OTHER |
| L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy | UNKNOWN |
| Fondazione Don Carlo Gnocchi ETS | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral anodal tDCS | Experimental | In post-stroke dysphagia |
|
| Bihemispheric anodal tDCS | Experimental | In post-stroke dysphagia |
|
| Sham tDCS | Placebo Comparator | In post-stroke dysphagia |
|
| Anodal tDCS in both hemispheres | Experimental | In Parkinson's disease dysphagia |
|
| Placebo tDCS | Placebo Comparator | In Parkinson's disease dysphagia |
|
| NMES + swallowing therapy | Experimental | In patients with post-stroke dysphagia and Parkinson's disease dysphagia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral anodal tDCS | Other | Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 6 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Penetration-Aspiration Scale (PAS) score | Changes in PAS. It's a 8-point scale to score the degree of airway invasion and patient response. | At baseline and 6 weeks post-treatment |
| Mann Assessment of Swallowing Ability (MASA) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Cosentino, MD | Translational Neurophysiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Neurophysiology | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27904911 | Background | 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. | |
| 26863627 | Background | Arnold 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010300 | Parkinson Disease |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Istituti Clinici Scientifici Maugeri SpA |
| OTHER |
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.
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Participants, care providers, and outcome assessors will all be blinded to group allocation to ensure double-blind conditions throughout the study
| Sham NMES + swallowing therapy | Placebo Comparator | In patients with post-stroke dysphagia and Parkinson's disease dysphagia |
|
| Bihemispheric anodal tDCS | Other | 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 tDCS | Other | 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 therapy | Other | Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients |
|
| Sham NMES + swallowing therapy | Other | Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients |
|
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.
| 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. | 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 . | At baseline and 6 weeks post-treatment |
| 29553959 | Background | Frost 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. |
| 23076886 | Background | Geeganage 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. |
| 27444734 | Background | Ginocchio 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. |
| 10341109 | Background | O'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. |
| 21441148 | Background | Kumar 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. |
| 25825989 | Background | Langmore 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. |
| 34755758 | Background | Liang 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. |
| 10187872 | Background | Mann 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. |
| 18230851 | Background | Robbins 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). |
| 23392916 | Background | Shigematsu 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. |
| 19760458 | Background | Speyer 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. |
| 29350775 | Background | Suntrup-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. |
| 22572022 | Background | Yang 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |