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Parkinson's Disease and ParkinsonismNCT07153692

Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

A study testing tDCS and Conventional Dysphagia Treatment in people with Parkinson's Disease and Parkinsonism and Dysphagia, run by Wang Ping at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
tDCS and Conventional Dysphagia Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteChina
Study dates
17 Jul 2025to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bo Wang, MD contact

wangke1121@zju.edu.cn

China1 site, 1 recruiting
  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Ping Wang, MS, 15158113194, 441350830@qq.com

    Bo Wang, MD, wangke1121@zju.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
tDCS, Conventional Dysphagia Treatment, sham tDCS
Keywords
Parkinson's disease, Atypical Parkinsonian Syndromes, dysphagia, tDCS, VFSS
Medical subject headings
Parkinson Disease, Parkinsonian Disorders, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    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).

  • Conventional Dysphagia TreatmentBehavioural

    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 tDCSDevice

    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.

Study groups in NCT07153692
Study groupRoleWhat they receive
real tDCS groupExperimentaltDCS 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.;
Receives: Device: tDCS; Behavioral: Conventional Dysphagia Treatment
sham tDCS groupSham comparatorSham 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.;
Receives: Behavioral: Conventional Dysphagia Treatment; Device: sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  2. 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;

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  3. oral residue

    Post-swallow residue was scored 0-3, with higher scores indicating more food residue and lower swallowing efficiency

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  4. 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.

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  5. Functional Connectivity (FC)

    Functional Connectivity (FC) refers to the statistical association or synchronization between spontaneous hemodynamic signals from different cortical regions, reflecting the coordinated activity of spatially distinct brain areas. It quantifies how closely the neural activity (inferred from blood oxygenation changes) in one brain region correlates with that in another, providing insights into the integration of brain networks.

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  6. vellaculae residue

    The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  7. pyriform sinuses residue

    The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

Secondary outcomes (4)
  1. temporal indicators

    TT, PTT, LVCrt, and so on.

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  2. spatial indicators

    hyoid bone advancement, hyoid bone elevation, PCR

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  3. Swallowing Disorder Questionnaire (SDQ)

    A swallowing function screening scale with 15 items, scored up to 44.5; higher scores indicate more severe dysphagia.

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

  4. Functional Oral Intake Scale (FOIS)

    7 levels in total, with Level 1 indicating the most severe feeding impairment and Level 7 indicating normal function.

    Measured: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start17 Jul 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153692
Sponsor's protocol ID
(2024)lunshenyan(1309)
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD sharing plan includes making the statistical results of the data publicly available to other researchers.

Publications

  • Ding X, Gao J, Xie C, Xiong B, Wu S, Cen Z, Lou Y, Lou D, Xie F, Luo W. Prevalence and clinical correlation of dysphagia in Parkinson disease: a study on Chinese patients. Eur J Clin Nutr. 2018 Jan;72(1):82-86. doi: 10.1038/ejcn.2017.100. Epub 2017 Jul 12.

    PubMed 28699630
  • Henry KA, Singh R, Zhang N, Lyons MK, McNett K, Neal MT, Mehta SH. Effect of STN/GPi DBS on swallowing function in Parkinson's disease as assessed by Video fluoroscopy: A retrospective study. Parkinsonism Relat Disord. 2022 Oct;103:136-140. doi: 10.1016/j.parkreldis.2022.08.017. Epub 2022 Sep 11.

    PubMed 36115199
  • Wang P, Wang B, Chen X, Xiong B, Xie F, Wu S, Tang Y, Chen S, Ding X, Liu P, Luo W. Six-Year Follow-Up of Dysphagia in Patients with Parkinson's Disease. Dysphagia. 2022 Oct;37(5):1271-1278. doi: 10.1007/s00455-021-10387-0. Epub 2021 Nov 26.

    PubMed 34826007
  • Gandhi P, Steele CM. Effectiveness of Interventions for Dysphagia in Parkinson Disease: A Systematic Review. Am J Speech Lang Pathol. 2022 Jan 18;31(1):463-485. doi: 10.1044/2021_AJSLP-21-00145. Epub 2021 Dec 10.

    PubMed 34890260
  • Dashtelei AA, Nitsche MA, Salehinejad MA, Habibi AH, Bakhtyiari J, Khatoonabadi AR. Adjunctive transcranial direct current stimulation to improve swallowing functions in Parkinson's disease. EXCLI J. 2024 Jan 18;23:95-107. doi: 10.17179/excli2023-6496. eCollection 2024.

    PubMed 38487086

Questions about this trial

What is this clinical trial studying?

A study testing tDCS and Conventional Dysphagia Treatment in people with Parkinson's Disease and Parkinsonism and Dysphagia, run by Wang Ping at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ping Wang, MS (15158113194, wangping6288@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rosenbek Penetration-Aspiration Scale (PAS): (time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07153692, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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