NCT07153692

Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

Clinical Efficacy and Mechanism of tDCS for Dysphagia in Patients With Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Wang Ping · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study aims to verify transcranial direct current stimulation(tDCS) efficacy for Parkinson's disease (PD)-related dysphagia and its mechanism. Subjects are randomly split into two groups: control (sham tDCS + conventional dysphagia treatment) and experimental (real tDCS + conventional treatment). Assessments will be conducted at baseline, after the completion of intervention, and at the 3-month follow-up. Swallowing function will be evaluated via gold-standard videofluoroscopic swallowing study (VFSS) and scales. Resting-state functional magnetic resonance imaging (rs-fMRI) or functional near-infrared spectroscopy (fNIRS) will be measures for tracking changes in abnormal brain regions/networks. Correlations between swallowing recovery and brain function changes, plus group imaging differences, will reveal tDCS's neurophysiological mechanism.

Detailed description

This study aims to verify the efficacy of tDCS in treating dysphagia in PD and explore its mechanism. Subjects are randomly divided into two groups: the control group receives sham tDCS as well as the conventional dysphagia treatment, while the experimental group undergoes real tDCS combined with conventional dysphagia treatment. All subjects will be evaluated before treatment, after treatment, and 3 months later (follow-up). Swallowing function in both groups will be assessed using the gold standard VFSS and swallowing scales. Additionally, techniques including amplitude of low frequency fluctuation (ALFF) and functional connectivity (FC) in rs-fMRI or fNIRS will be used to observe changes in abnormal brain regions and brain network connectivity before and after treatment in both groups. This study will also explore the correlation between swallowing function recovery and the alteration of brain function, compare the imaging differences between the two groups, and thereby reveal the neurophysiological mechanism underlying tDCS in the treatment of PD-related dysphagia.

Conditions

• Parkinson's Disease and Parkinsonism
• Dysphagia

Interventions

Type	Name	Description
DEVICE	tDCS	The IS200 intelligent electrical stimulator, manufactured in Chengdu, Sichuan, will be used. The electrode pads are 4cm × 6cm in size. The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The specific positioning will follow the international 10-20 electroencephalographic system: the left S1/M1 area is located at the midpoint of the line connecting C3 and T3 in the left hemisphere; the right S1/M1 area is located at the midpoint of the line connecting C4 and T4 in the right hemisphere. The cathode will be placed on the contralateral supraorbital margin. The S1/M1 areas of the left and right hemispheres will be stimulated alternately, with a current intensity of 1.6mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).
BEHAVIORAL	Conventional Dysphagia Treatment	1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.; 2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;
DEVICE	sham tDCS	According to previous literature, the electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current will be adjusted to 0.05mA.

Timeline

• Start date: 2025-07-17
• Primary completion: 2029-12-31
• Completion: 2030-03-31
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China