Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients
ConditionParkinson Disease, Idiopathic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorKezhong Zhang
About this trial
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.
Eligibility criteria
Qualifiers
Age 55-75 years.
Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
Hoehn and Yahr (H&Y) stage ≤ 2.5 at medication initiation.
Parkinson's disease duration ≤ 3 years.
Disqualifiers
Patients with cognitive impairment (MMSE < 24 and/or MoCA < 26) or mental illnesses, or those unable to cooperate for other reasons.
Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01.
Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.
Previous treatment with vagus nerve stimulation.
Trial design
Treatments tested in this trial
- taVNS real stimulation
- taVNS sham stimulation
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kezhong Zhang
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Sponsor institution
Source ClinicalTrials.gov