Tests ear-based nerve stimulation in people with early Parkinson's disease
Tests ear nerve stimulation against a sham device in adults with early Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients
Key facts
- Where
- Nanjing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 75 years old?
Source: NCT06665113, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kezhong Zhang
- Trial code
- NCT06665113
- Record updated
- 14 January 2025
- Original description
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.Read full original descriptionShow less
A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients
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.
Inclusion: 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; Receiving standard anti-Parkinson's disease medication treatment.
Exclusion: 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; MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts > 1 cm³ or > 3 lacunar infarcts; Previous history of stroke or intracranial mass lesions; Concurrent participation in other clinical trials; Patients with cognitive impairment (MMSE < 24 and/or MoCA < 26) or mental illnesses, or those unable to cooperate for other reasons; Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation; Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related; Patients with existing or potential cardiovascular diseases; Ophthalmic diseases affecting eye movements; Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae); Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years; Patients with a history of PD-related freezing episodes or falls; Inability to receive the required treatment and follow-up due to geographic reasons; Any subject with an upper limb UPDRS tremor score of 3 or higher.