Cerebellar Transcranial Direct Current Stimulation for Dysphagia After Supratentorial Stroke

Zhejiang Provincial People's Hospital

Status: Not yet enrolling

Conditions: Dysphagia After Stroke

Treatments: Other: Sham tDCS; Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07212634

2024KY739

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 76 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 4 patient groups

Cerebellar tDCS Group

Experimental group

Description:

This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral cerebellar hemispheres.

Treatment:

Device: Transcranial Direct Current Stimulation

Cortical (Suprahyoid Muscle) tDCS Group

Active Comparator group

Description:

This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS targeting the cortical representation areas of the suprahyoid muscles in both cerebral hemispheres.

Treatment:

Device: Transcranial Direct Current Stimulation

Combined Cerebellar and Cortical (Suprahyoid Muscle) tDCS Group

Active Comparator group

Description:

This group will include 19 patients. The patients in this group will receive 20 minutes of tDCS over the bilateral suprahyoid muscle cortical areas and 20 minutes over the bilateral cerebellar hemispheres.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS Group

Sham Comparator group

Description:

This group will include 19 patients. The patients in this group received sham stimulation applied to the same area for the same duration.

Treatment:

Other: Sham tDCS