tDCS to improve swallowing in Parkinson's disease
Clinical Efficacy and Mechanism of tDCS for Dysphagia in Patients With Parkinson's Disease
This study tests whether adding transcranial direct current stimulation (tDCS) to standard swallowing therapy helps people with Parkinson's disease who have dysphagia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07153692 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study will assign people with Parkinson's-related dysphagia to real tDCS plus conventional dysphagia treatment or sham tDCS plus conventional treatment. Swallowing function will be measured at baseline, after the intervention, and at a 3-month follow-up using videofluoroscopic swallowing study (VFSS) and clinical swallowing scales. Brain function will be tracked with resting-state fMRI or functional near-infrared spectroscopy (fNIRS), using ALFF and functional connectivity analyses to map changes in networks and regions. The study will correlate imaging changes with swallowing recovery to explore the neurophysiological mechanism of tDCS.
Who should consider this trial
Good fit: Adults with Parkinson's disease or atypical parkinsonian syndromes (MSA or PSP) who have dysphagia confirmed by VFSS, intact cognition (MMSE >23), and the ability to consent and cooperate are appropriate candidates.
Not a fit: Patients whose swallowing problems are caused by other diseases, those with active pneumonia or severe cardiac/renal failure, metal implants, or significant cognitive impairment or inability to cooperate are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, tDCS could improve swallowing safety and function in people with Parkinson's, reducing aspiration risk and improving nutrition and quality of life.
How similar studies have performed: tDCS has shown promising results for post-stroke dysphagia and small pilot studies in Parkinson's suggest potential benefit, but robust randomized trials specifically in PD-related dysphagia are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Ping Wang — Second Affiliated Hospital of Zhejiang University School of Medicine
- Study coordinator: Ping Wang, MS
- Email: wangping6288@zju.edu.cn
- Phone: 15158113194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.