Parkinson's Disease, Stroke, Complication
Conditions
Keywords
Dysphagia, Stroke, Parkinson's Disease, Transcranial Direct Current Stimulation (tDCS), Neuromuscular Electrical Stimulation (NMES), Swallowing Therapy
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.
Interventions
OTHERUnilateral anodal tDCS
Evaluates the effects of unilateral, anodal tDCS applied to the swallowing motor cortex in post-stroke patients with dysphagia
OTHERBihemispheric 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
OTHERSham 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
OTHERNMES + swallowing therapy
Examines the effects of NMES therapy on swallowing function in both post-stroke and Parkinson's disease patients
OTHERSham NMES + swallowing therapy
Examines the effects of Sham therapy on swallowing function in both post-stroke and Parkinson's disease patients
Sponsors
ASST Santi Paolo e Carlo
L. Sacco Department of Biomedical and Clinical Sciences, Milano, Italy
Fondazione Don Carlo Gnocchi Onlus
Istituti Clinici Scientifici Maugeri SpA
IRCCS National Neurological Institute C. Mondino Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, care providers, and outcome assessors will all be blinded to group allocation to ensure double-blind conditions throughout the study
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
Italy
Outcome results
None listed