Innovative Treatments for Neurogenic Dysphagia

Not Applicable

Completed

• Conditions: Stroke, Complication; Parkinson's Disease

• Registration Number: NCT07152899
• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

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. 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.

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 Timeline

• Study Start: 2021-06-15
• Primary Completion: 2025-01-15
• Status Verified: 2025-04
• Study Completion: 2025-05-15
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dysphagia Outcome and Severity Scale (DOSS) score	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 Outcome Measures

Name	Time	Method
Penetration-Aspiration Scale (PAS) score	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.
Mann Assessment of Swallowing Ability (MASA) score	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.
Swallowing Quality of Life (SWAL-QOL) questionnaire	At baseline and 6 weeks post-treatment	The SWAL-QOL questionnaire was constructed for use in clinical research for patients with oropharyngeal dysphagia.
Motor Evoked Potentials (MEP) assessment	At baseline and 6 weeks post-treatment	Motor Evoked Potentials (MEP) assessment of tongue muscle response in a small patients subgroup .

Trial Locations

Locations (1)

Translational Neurophysiology; 🇮🇹 Pavia, Italy