Cerebellar Transcranial Direct Current Stimulation for Dysphagia After Supratentorial Stroke

NCT ID: NCT07212634

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed 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).

Conditions

Dysphagia After Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cerebellar tDCS Group

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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

Cortical (Suprahyoid Muscle) tDCS Group

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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

Combined Cerebellar and Cortical (Suprahyoid Muscle) tDCS Group

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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 tDCS Group

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: OTHER

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

Interventions

Transcranial Direct Current Stimulation

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

Intervention Type: DEVICE

Sham tDCS

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junmei Lai, MD

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sisi Wang, PhD

Role: CONTACT

415169277@qq.com

86-18158510955

Other Identifiers

2024KY739

Identifier Type: -

Identifier Source: org_study_id