Parkinson's Disease
Conditions
Interventions
Experimental Group:taVNS+ anti-PD medication
Control Group:non-taVNS + anti-PD medication
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the 2015 International Movement Disorder Society (MDS) clinical diagnostic criteria for Parkinson's disease. (2) Age between 30 and 75 years, with no gender limitation. (3) Receiving standard anti-PD medication with stable symptom control prior to enrollment. (4) No severe abnormalities on electrocardiogram (e.g., atrial flutter, atrial fibrillation, ventricular fibrillation, or atrioventricular block). (5) No use of medications that may affect the gut microbiota within the past 3 months (e.g., probiotics). (6) Right-handed. (7) Willing to participate and able to provide written informed consent, with good compliance to study procedures.
Exclusion criteria
Exclusion criteria: (1) Secondary parkinsonism with a clearly identifiable cause or Parkinsonian syndromes associated with other neurodegenerative disorders. (2) History of psychiatric illness (e.g., schizophrenia, depression, somatoform disorders) or long-term use of antipsychotic medications. (3) Cognitive impairment. (4) Evidence of structural brain lesions (e.g., cerebrovascular disease, epilepsy, or tumor) on previous cranial MRI examination. (5) Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, insulin pump). (6) History of surgical treatments such as gamma knife surgery, deep brain lesioning, or deep brain stimulation. (7) Severe impairment of heart, lung, liver, or kidney function; comorbid malignant tumors; various hemorrhagic diseases; acute infectious diseases; high fever or febrile illnesses, or other severe conditions. (8) History of substance abuse. (9) Allergic reaction to skin preparation or lesions/infection at the auricular stimulation site. (10) Contraindications to MRI scanning. (11) Participation in other clinical trials within the past six months. (12) Pregnant or lactating women, or those planning pregnancy within six months. (13) Participation with auricular skin infections, breaks, or other conditions unsuitable for taVNS. (14) Receipt of taVNS intervention within the past 3 months. (15) Other reasons as determined by the investigator that make the participation unlikely to comply with the protocol or unsuitable for any reason, such as frequent long-distance travel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in the UPDRS Part III score at the end of the 4-week treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in UPDRS Part III score;Change from baseline in UPDRS Total score;Change from baseline in UPDRS Part I score;Change from baseline in UPDRS Part II score;Change from baseline in UPDRS Part IV score;Non-Motor Symptoms Scale (NMSS);Hoehn and Yahr Staging (H-Y Staging);Hamilton Depression Rating Scale (HAMD);Geriatric Depression Scale (GDS);Hamilton Anxiety Rating Scale (HAMA);State-Trait Anxiety Inventory (STAI);Montreal Cognitive Assessment (MoCA);Epworth Sleepiness Scale (ESS); Pittsburgh Sleep Quality Index (PSQI);Fatigue Severity Scale (FSS);Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT);39-item Parkinson's Disease Questionnaire (PDQ-39);Schwab&England scores;Neuro-QoL;Behavioral Indicators;Constitution Assessment;Gut-Brain Peptide Levels;Gut Microbiota;fMRI;HRV; | — |
Countries
China
Contacts
Public ContactChengwei Fu
Hubei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed