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Completed

NCT Number: NCT07152899

Innovative Treatments for Neurogenic Dysphagia

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. 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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Unilateral anodal tDCS

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Penetration-Aspiration Scale (PAS) score

    Time frame: At baseline and 6 weeks post-treatment

    Changes in PAS. It's a 8-point scale to score the degree of airway invasion and patient response.

  2. Mann Assessment of Swallowing Ability (MASA) score

    Time frame: At baseline and 6 weeks post-treatment

    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.

  3. Swallowing Quality of Life (SWAL-QOL) questionnaire

    Time frame: At baseline and 6 weeks post-treatment

    The SWAL-QOL questionnaire was constructed for use in clinical research for patients with oropharyngeal dysphagia.

  4. Motor Evoked Potentials (MEP) assessment

    Time frame: At baseline and 6 weeks post-treatment

    Motor Evoked Potentials (MEP) assessment of tongue muscle response in a small patients subgroup .

Sponsors and collaborators

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Other

Collaborators

  • ASST Santi Paolo e Carlo
  • Fondazione Don Carlo Gnocchi ETS
  • Istituti Clinici Scientifici Maugeri SpA
  • L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy

Registry information

Official study title

New Approaches for the Treatment of Post-stroke Dysphagia and Dysphagia in Parkinson's Disease

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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