Actively Recruiting
A Double-blinded, Randomized Study to Explore Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation in Early Parkinson's Disease Patients
Led by Kezhong Zhang · Updated on 2025-01-14
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of long-term transcutaneous auricular vagus nerve stimulation (taVNS) in patients with early-stage Parkinson's disease. This randomized, double-blind, controlled trial aims to explore a new treatment approach to potentially delay the progression of Parkinson's disease in adults aged 55 to 75 years who have been diagnosed based on specific clinical criteria and have mild disease severity. Participants receive either real or sham taVNS stimulation alongside their standard anti-Parkinson's medication. For the real stimulation group, electrodes deliver pulses near the auricular branch of the vagus nerve in the left ear for a 30-minute session each day, at least five days per week, over 270 consecutive days. The sham group receives stimulation on the earlobes with the same schedule and device settings to serve as a comparison. Throughout the study, participants undergo regular assessments using motor function scales like MDS-UPDRS and imaging techniques such as diffusion tensor imaging to measure changes in brain structures. Evaluations occur at baseline and multiple follow-up points up to approximately 570 days. Researchers monitor symptoms, movement parameters, and disease stage while ensuring participant safety and adherence to the treatment and follow-up schedule.
CONDITIONS
Brief Title
Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 75 years
- Clinically diagnosed idiopathic Parkinson's disease according to 2016 Chinese criteria
- Hoehn and Yahr stage of 2.5 or less at medication start
- Parkinson's disease duration of 3 years or less
- Receiving standard anti-Parkinson's disease medication treatment
You will not qualify if you...
- Cognitive impairment (MMSE < 24 and/or MoCA < 26), mental illness, or inability to cooperate
- Use of neuroprotective medications or drugs affecting dopamine metabolism within 90 days before baseline
- Previous treatment with vagus nerve stimulation
- MRI contraindications or brain abnormalities like past hemorrhages or infarcts
- Contraindications for taVNS including cardiac pacemakers, history of DBS surgery, ear conditions
- Atypical or secondary Parkinsonian syndromes or drug/toxin-related symptoms
- History of stroke or intracranial mass lesions
- Existing or potential cardiovascular diseases
- Ophthalmic diseases affecting eye movements
- Neurological or musculoskeletal conditions interfering with gait or balance
- Severe organic diseases with life expectancy under 2 years
- Participation in other clinical trials
- Inability to attend treatment and follow-up due to geographic reasons
- Upper limb tremor score of 3 or higher on UPDRS
- History of Parkinson's-related freezing episodes or falls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 270 consecutive days
Participants receive either real or sham transcutaneous auricular vagus nerve stimulation (taVNS) daily for at least 5 days per week.
Daily 30-minute stimulation sessions at home; follow-up visits approximately at 30, 90, 180, 360, 540, and 570 days
Duration - Up to 210 days after treatment ends
Participants are monitored with periodic assessments of Parkinson's disease symptoms and brain imaging after the intervention.
Follow-up visits approximately at 540 and 570 days
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 211200
Actively Recruiting
Research Team
K
Kezhong Zhang, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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