Study Results
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Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2021-06-15
2025-05-15
Brief Summary
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1. Unilateral, bihemispheric, or sham transcranial Direct Current Stimulation (tDCS) in post-stroke dysphagia (patients ≥2 weeks from onset).
2. Bihemispheric or sham tDCS in Parkinson's disease-related dysphagia.
3. Neuromuscular stimulation therapy in post-stroke and Parkinson's disease dysphagia.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Unilateral anodal tDCS
In post-stroke dysphagia
Unilateral anodal tDCS
Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia
Bihemispheric anodal tDCS
In post-stroke dysphagia
Bihemispheric anodal tDCS
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
In post-stroke dysphagia
Sham tDCS
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
Anodal tDCS in both hemispheres
In Parkinson's disease dysphagia
Bihemispheric anodal tDCS
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
Placebo tDCS
In Parkinson's disease dysphagia
Sham tDCS
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
In patients with post-stroke dysphagia and Parkinson's disease dysphagia
NMES + swallowing therapy
Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients
Sham NMES + swallowing therapy
In patients with post-stroke dysphagia and Parkinson's disease dysphagia
Sham NMES + swallowing therapy
Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients
Interventions
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Unilateral anodal tDCS
Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia
Bihemispheric anodal tDCS
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
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
Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients
Sham NMES + swallowing therapy
Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Non-neurogenic causes of dysphagia
* Contraindications to tDCS or NMES
* Cognitive impairment affecting compliance with treatment
18 Years
85 Years
ALL
No
Sponsors
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ASST Santi Paolo e Carlo
OTHER
L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Cosentino, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Neurophysiology
Locations
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Translational Neurophysiology
Pavia, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
Other Identifiers
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Neu-Dysphagia
Identifier Type: -
Identifier Source: org_study_id
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