Actively Recruiting

Phase Not Applicable
Age: 55Years - 75Years
All Genders
NCT06665113

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

Led by Kezhong Zhang · Updated on 2025-01-14

12

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.

CONDITIONS

Official Title

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

Who Can Participate

Age: 55Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 55-75 years
  • Diagnosed with idiopathic Parkinson's disease according to 2016 Chinese diagnostic criteria
  • Hoehn and Yahr stage 2.5 or less at medication start
  • Parkinson's disease duration of 3 years or less
  • Receiving standard anti-Parkinson's disease medication treatment
Not Eligible

You will not qualify if you...

  • Cognitive impairment (MMSE < 24 or MoCA < 26), mental illness, or inability to cooperate
  • Use of neuroprotective drugs or dopamine-affecting medications within 90 days before baseline
  • Previous vagus nerve stimulation treatment
  • MRI contraindications or significant brain abnormalities on MRI
  • Contraindications for taVNS such as pacemakers, history of DBS surgery, or ear conditions
  • Atypical or secondary Parkinsonian syndromes or drug/toxin-related symptoms
  • Previous stroke or intracranial mass lesions
  • Existing or potential cardiovascular diseases
  • Eye diseases affecting eye movement
  • Other neurological or musculoskeletal disorders affecting gait or balance
  • Severe organic diseases with life expectancy under 2 years
  • Participation in other clinical trials
  • Inability to attend required treatment and follow-up due to location
  • Upper limb tremor score of 3 or higher on UPDRS
  • History of Parkinson's freezing episodes or falls

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 211200

Actively Recruiting

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Research Team

K

Kezhong Zhang, Professor

CONTACT

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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