Innovative Treatments for Neurogenic Dysphagia

NCT07152899 | Completed

• 1 other identifier: Neu-Dysphagia
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 1.Unilateral, bihemispheric, or sham transcranial Direct Current Stimulation (tDCS) in post-stroke dysphagia (patients ≥2 weeks from onset).
2. 2.Bihemispheric or sham tDCS in Parkinson's disease-related dysphagia.
3. 3.Neuromuscular stimulation therapy in post-stroke and Parkinson's disease dysphagia.

Conditions

Stroke, Complication; Parkinson's Disease

Keywords

Dysphagia; Stroke; Parkinson's Disease; Transcranial Direct Current Stimulation (tDCS); Neuromuscular Electrical Stimulation (NMES); Swallowing Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Penetration-Aspiration Scale (PAS) score

  At baseline and 6 weeks post-treatment

• Mann Assessment of Swallowing Ability (MASA) score

  At baseline and 6 weeks post-treatment

• Swallowing Quality of Life (SWAL-QOL) questionnaire

  At baseline and 6 weeks post-treatment

• Motor Evoked Potentials (MEP) assessment

  At baseline and 6 weeks post-treatment

Study Arms (7)

Unilateral anodal tDCS

EXPERIMENTAL

In post-stroke dysphagia

Other: Unilateral anodal tDCS

Bihemispheric anodal tDCS

EXPERIMENTAL

In post-stroke dysphagia

Other: Bihemispheric anodal tDCS

Sham tDCS

PLACEBO COMPARATOR

In post-stroke dysphagia

Other: Sham tDCS

Anodal tDCS in both hemispheres

EXPERIMENTAL

In Parkinson's disease dysphagia

Other: Bihemispheric anodal tDCS

Placebo tDCS

PLACEBO COMPARATOR

In Parkinson's disease dysphagia

Other: Sham tDCS

NMES + swallowing therapy

EXPERIMENTAL

In patients with post-stroke dysphagia and Parkinson's disease dysphagia

Other: NMES + swallowing therapy

Sham NMES + swallowing therapy

PLACEBO COMPARATOR

In patients with post-stroke dysphagia and Parkinson's disease dysphagia

Other: Sham NMES + swallowing therapy

Interventions

Unilateral anodal tDCS OTHER

Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia

Unilateral anodal tDCS

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

Anodal tDCS in both hemispheres; Bihemispheric anodal tDCS

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

Placebo tDCS; Sham tDCS

NMES + swallowing therapy OTHER

Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients

NMES + swallowing therapy

Sham NMES + swallowing therapy OTHER

Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients

Sham NMES + swallowing therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• ASST Santi Paolo e Carlo: collaborator
• L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

Translational Neurophysiology

Pavia, 27100, Italy

Location

Related Publications (15)

• 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.

  PMID: 27904911 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.

  PMID: 26863627 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.

  PMID: 29553959 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.

  PMID: 23076886 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.

  PMID: 27444734 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.

  PMID: 10341109 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.

  PMID: 21441148 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.

  PMID: 25825989 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.

  PMID: 34755758 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.

  PMID: 10187872 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).

  PMID: 18230851 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.

  PMID: 23392916 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.

  PMID: 19760458 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.

  PMID: 29350775 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.

  PMID: 22572022 BACKGROUND

MeSH Terms

Conditions

Stroke; Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Giuseppe Cosentino, MD

  Translational Neurophysiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, care providers, and outcome assessors will all be blinded to group allocation to ensure double-blind conditions throughout the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: June 15, 2021
• Primary Completion: January 15, 2025
• Study Completion: May 15, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-04

Locations

IT (1)