Cerebellar Transcranial Direct Current Stimulation for Dysphagia After Supratentorial Stroke

N/ANot Yet RecruitingNCT07212634

Zhejiang Provincial People's Hospital76 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Interventions

Transcranial Direct Current StimulationDEVICE

Different experimental groups received tDCS stimulation at the following distinct sites: bilateral cerebellar hemispheres, bilateral cortical areas corresponding to the suprahyoid muscles, and combined bilateral cerebellar hemispheres alongside bilateral cortical areas corresponding to the suprahyoid muscles. Stimulation parameters: 2 mA constant current, 20 minutes per session Treatment regimen: 5 sessions per week for 2 consecutive weeks

Sham tDCSOTHER

The patients in this group will receive sham stimulation applied to the same area for the same duration.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with supratentorial stroke, confirmed by cranial MRI or CT as having cerebral infarction or hemorrhage; 2. Stable vital signs after conventional treatment, with disease duration between 1 and 6 months; 3. 30 ≤ age ≤75 years, male or female; 4. Presence of dysphagia, drinking-induced coughing, and a Kubota Water Drinking Test grade of 3-5; 5. Signed informed consent form. Exclusion Criteria: 1. MRI-confirmed lesion involving the cerebellum; 2. Unstable vital signs; 3. Significant cognitive impairment (MMSE score ≤ 24); 4. Presence of swallowing apraxia; 5. Unwilling or unable to cooperate with treatment, or taking any medication that may affect swallowing function or nervous system activity.

Outcomes

Primary Outcomes

Standardized Swallowing Assessment (SSA)

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.

Time frame: at baseline (pre-treatment), at 2 weeks after intervention, at 3-month follow-up]

Video fluroscopic swallowing study (VFSS)

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.