Efficacy and Mechanisms of Cerebellar Transcranial Direct Current Stimulation for Treating Dysphagia After Supratentorial Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Standardized Swallowing Assessment (SSA)
研究概览
简要总结
It is estimated that 400,000 to 800,000 people worldwide develop neurogenic dysphagia annually. Stroke represents the most common etiology, with approximately 65% of acute stroke patients experiencing pharyngeal swallowing difficulties. Clinical manifestations of dysphagia vary widely in severity and may include residue, reflux, delayed swallowing initiation, aspiration, and cricopharyngeal muscle dysfunction. Due to its detrimental effects on nutrition, respiration, and psychosocial well-being, dysphagia significantly impairs patients' quality of life. Furthermore, the inability to swallow safely and efficiently can lead to serious complications such as aspiration pneumonia, malnutrition, and depression. The traditional swallowing rehabilitation treatment has limited effect in clinical practice, which makes it necessary to search for new effective swallowing methods.
Conventional swallowing rehabilitation often yields limited clinical benefits, highlighting the urgent need for more effective therapeutic strategies. Transcranial direct current stimulation (tDCS) is a non-invasive and safe neuromodulation technique that has shown promise in the field of neurorehabilitation. Its mechanisms extend beyond immediate cortical modulation and cerebral blood flow changes to include the regulation of synaptic plasticity, neurotransmitters such as glutamate and GABA, and excitability in remote subcortical regions. In recent years, tDCS has been increasingly applied to various neurological disorders, including post-stroke motor impairment, dysphagia, aphasia, depression, addiction, and spinal cord injury-related movement disorders. Currently, tDCS is being explored to elucidate its regulatory effects on cerebellar swallowing control, positioning it as a potential innovative treatment for neurogenic dysphagia.
详细描述
This multicentre randomized controlled trial will enroll 76 patients with dysphagia after stroke from Zhejiang Provincial People' s Hospital. All patients will be centrally randomized to either tDCS combined with traditional swallowing rehabilitation or traditional rehabilitation alone. The tDCS group will be further divided into three subgroups based on stimulation parameters. Observation indicators will be Standardized Swallowing Assessment (SSA), videofluroscopic swallowing study (VFSS) and neuroimaging examinations including fMRI, MRS And quantitative electroencephalography (QEEG).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with supratentorial stroke, confirmed by cranial MRI or CT as having cerebral infarction or hemorrhage;
- •Stable vital signs after conventional treatment, with disease duration between 1 and 6 months;
- •30 ≤ age ≤75 years, male or female;
- •Presence of dysphagia, drinking-induced coughing, and a Kubota Water Drinking Test grade of 3-5;
- •Signed informed consent form.
排除标准
- •MRI-confirmed lesion involving the cerebellum;
- •Unstable vital signs;
- •Significant cognitive impairment (MMSE score ≤ 24);
- •Presence of swallowing apraxia;
- •Unwilling or unable to cooperate with treatment, or taking any medication that may affect swallowing function or nervous system activity.
结局指标
主要结局
Standardized Swallowing Assessment (SSA)
时间窗: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up]
Process: A clinician-administered scale performed in three sequential parts. Part 1 examines basic clinical signs (e.g., consciousness, lip closure, voluntary cough). Part 2 involves observing the patient swallowing 5ml of water three times. If no abnormalities are detected, Part 3 requires the patient to swallow 60ml of water, noting the time and signs of aspiration. Assessment: The total score (ranging from 18 to 46) is calculated. A higher score indicates more severe swallowing impairment.
Video fluroscopic swallowing study (VFSS)
时间窗: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up
Process: Patients will swallow barium-coated boluses of varying consistencies (liquid, semi-solid) under real-time X-ray (videofluoroscopy). The procedure is recorded for frame-by-frame analysis. Assessment: The primary metric from VFSS will be the Penetration-Aspiration Scale (PAS ) score, which quantifies the depth and patient response to airway invasion. Additionally, the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale or component scores for oral and pharyngeal phase efficiency and safety may be used. A lower PAS score indicates better airway protection.
次要结局
- Change in Surface electromyography (sEMG)(at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up)
- Change in Functional magnetic resonance imaging (fMRI)(at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up)
- Change in Magnetic resonance spectroscopy (MRS)(at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up)
- Change in Quantitative electroencephalography (QEEG)(at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up)
研究者
Junmei Lai, MD
Attending Physician
Zhejiang Provincial People's Hospital