Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorWang Ping
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
tDCS
DeviceThe 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).
Conventional Dysphagia Treatment
Behavioral1. 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 tDCS
DeviceAccording 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: real tDCS groupExperimental treatment 2 interventions
Group B: sham tDCS groupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Rosenbek Penetration-Aspiration Scale (PAS):
Scored 1-8, with higher scores indicating poorer swallowing safety. 1. Level 1: The bolus does not enter the airway; it remains entirely within the oral cavity or pharynx and is propelled normally. 2. Level 2: The bolus enters the supraglottic area (e.g., vallecula) but does not touch the vocal cords, and is completely cleared (e.g., via swallowing or coughing). 3. Level 3: The bolus enters the supraglottic area without touching the vocal cords, but residue remains (not fully cleared). 4. Level 4: The bolus touches the vocal cords but does not enter the subglottic airway, and is completely cleared. 5. Level 5: The bolus touches the vocal cords without entering the subglottic airway, but residue remains. 6. Level 6: The bolus enters the subglottic airway (into the trachea) but is completely cleared by the patient (e.g., via coughing). 7. Level 7: The bolus enters the subglottic airway; the patient exhibits protective responses (e.g., coughing) but cannot fully clear it, leaving
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up2
Videofluoroscopic Dysphagia Scale (VDS)
14 items in total, including 7 items for oral-phase swallowing function and 7 for pharyngeal-phase function, used to assess overall swallowing function;
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up3
oral residue
Post-swallow residue was scored 0-3, with higher scores indicating more food residue and lower swallowing efficiency
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up4
Amplitude of Low Frequency Fluctuation (ALFF)
ALFF focuses on the low-frequency components of these HbO/HbR time series. It is defined as the average amplitude of hemodynamic signal fluctuations within a specific low-frequency range (typically 0.01-0.1 Hz, though the exact band may vary by study). This range is chosen because it captures slow, spontaneous oscillations in cerebral blood flow and oxygenation, which are hypothesized to reflect synchronized neural activity across brain regions (e.g., default mode network, sensorimotor networks). Mathematically, ALFF quantifies the "strength" of these low-frequency oscillations: a higher ALFF value indicates more prominent or intense fluctuations in the target frequency band, suggesting greater spontaneous hemodynamic (and thus neural) activity in that brain region.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-upSecondary outcomes
1
temporal indicators
TT, PTT, LVCrt, and so on.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up2
spatial indicators
hyoid bone advancement, hyoid bone elevation, PCR
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up3
Swallowing Disorder Questionnaire (SDQ)
A swallowing function screening scale with 15 items, scored up to 44.5; higher scores indicate more severe dysphagia.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up4
Functional Oral Intake Scale (FOIS)
7 levels in total, with Level 1 indicating the most severe feeding impairment and Level 7 indicating normal function.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-upOther outcomes
1
Unified Parkinson's Disease Rating Scale-III (UPDRS-III)
14 items, scored up to 56; higher scores indicate more severe motor dysfunction.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up2
Swallowing Quality of Life Questionnaire (SWAL-QOL)
The SWAL-QOL is a patient-reported outcome tool designed to assess the impact of oropharyngeal dysphagia on health-related quality of life. It Comprises 44 items. it evaluates both subjective experiences (e.g., psychological burden) and clinical symptoms (e.g., choking, food sticking) through self-reported responses.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-up3
Non-Motor Symptoms Scale (NMSS) for Parkinson's Disease
30 items, scored up to 210; higher scores indicate more severe non-motor symptoms.
Time frame
at baseline, after the completion of 10 days of intervention, at the 3-month follow-upSponsors and contacts
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Wang Ping
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
Source ClinicalTrials.gov