Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

NCT ID: NCT07153692

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2030-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.;

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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 Treatment

Intervention Type: BEHAVIORAL

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 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.;

Group Type: SHAM_COMPARATOR

Conventional Dysphagia Treatment

Intervention Type: BEHAVIORAL

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 tDCS

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: DEVICE

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.;

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wang Ping

OTHER

Sponsor Role: lead

Responsible Party

Wang Ping

senior therapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ping Wang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Zhejiang University School of Medicine

Locations

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Wang, MS

Role: CONTACT

wangping6288@zju.edu.cn

15158113194

Bo Wang, MD

Role: CONTACT

wangke1121@zju.edu.cn

Facility Contacts

Ping Wang, MS

Role: primary

441350830@qq.com

15158113194

Bo Wang, MD

Role: backup

wangke1121@zju.edu.cn

References

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.

Reference Type: RESULT

PMID: 28699630 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36115199 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34826007 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34890260 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38487086 (View on PubMed)

Other Identifiers

（2024）lunshenyan（1309）

Identifier Type: -

Identifier Source: org_study_id