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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Meet the Chinese Diagnostic Criteria for Parkinson's Disease (2016) or MDS Diagnostic Criteria for Multiple System Atrophy or Progressive Supranuclear Palsy;

• VFSS examination indicates dysphagia;

• Mini-Mental State Examination (MMSE) score \>23;

• Willing to cooperate with the study and sign the informed consent form;

Locations
Other Locations
China
Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Ping Wang, MS
wangping6288@zju.edu.cn
15158113194
Backup
Bo Wang, MD
wangke1121@zju.edu.cn
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 58
Treatments
Experimental: real tDCS group
tDCS Treatment Protocol The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). 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).~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.;
Sham_comparator: sham tDCS group
Sham tDCS Treatment Protocol The electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current is 0.05 mA. 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).~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.;
Related Therapeutic Areas
Swallowing Difficulty
Movement Disorders
Parkinson's Disease
Sponsors
Leads: Wang Ping

This content was sourced from clinicaltrials.gov

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