Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD

Official title

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

Overview

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.

Interventions

• Device 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 a
• Behavioral 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.;
• Device 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.

Primary outcome measures

• Rosenbek Penetration-Aspiration Scale (PAS): [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• Videofluoroscopic Dysphagia Scale (VDS) [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• oral residue [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• Amplitude of Low Frequency Fluctuation (ALFF) [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• Functional Connectivity (FC) [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• vellaculae residue [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• pyriform sinuses residue [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]

Secondary outcome measures (4)

• temporal indicators [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• spatial indicators [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• Swallowing Disorder Questionnaire (SDQ) [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]
• Functional Oral Intake Scale (FOIS) [Time frame: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38487086

Identifiers

NCT: NCT07153692 · （2024）lunshenyan（1309）

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗