Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

Wang Ping

Status: Enrolling

Conditions: Dysphagia; Parkinson's Disease and Parkinsonism

Treatments: Device: tDCS; Behavioral: Conventional Dysphagia Treatment; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT07153692

（2024）lunshenyan（1309）

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• Comorbid with other diseases that cause dysphagia;
• Comorbid with pneumonia, or severe cardiac/renal insufficiency;
• Having metal implants in the body
• With cognitive impairment or inability to cooperate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups

real tDCS group

Experimental group

Description:

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.;

Treatment:

Behavioral: Conventional Dysphagia Treatment

Device: tDCS

sham tDCS group

Sham Comparator group

Description:

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.;

Treatment:

Device: sham tDCS

Behavioral: Conventional Dysphagia Treatment