New Approaches for the Treatment of Post-stroke Dysphagia and Dysphagia in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Dysphagia Outcome and Severity Scale (DOSS) score
研究概览
简要总结
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:
- Unilateral, bihemispheric, or sham transcranial Direct Current Stimulation (tDCS) in post-stroke dysphagia (patients ≥2 weeks from onset).
- Bihemispheric or sham tDCS in Parkinson's disease-related dysphagia.
- Neuromuscular stimulation therapy in post-stroke and Parkinson's disease dysphagia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants, care providers, and outcome assessors will all be blinded to group allocation to ensure double-blind conditions throughout the study
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Unilateral anodal tDCS
In post-stroke dysphagia
干预措施: Unilateral anodal tDCS (Other)
Bihemispheric anodal tDCS
In post-stroke dysphagia
干预措施: Bihemispheric anodal tDCS (Other)
Sham tDCS
In post-stroke dysphagia
干预措施: Sham tDCS (Other)
Anodal tDCS in both hemispheres
In Parkinson's disease dysphagia
干预措施: Bihemispheric anodal tDCS (Other)
NMES + swallowing therapy
In patients with post-stroke dysphagia and Parkinson's disease dysphagia
干预措施: NMES + swallowing therapy (Other)
Placebo tDCS
In Parkinson's disease dysphagia
干预措施: Sham tDCS (Other)
Sham NMES + swallowing therapy
In patients with post-stroke dysphagia and Parkinson's disease dysphagia
干预措施: Sham NMES + swallowing therapy (Other)
结局指标
主要结局
Dysphagia Outcome and Severity Scale (DOSS) score
时间窗: 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.
次要结局
- 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)