---
title: Ear stimulation slows Parkinson progression
nct_id: NCT06665113
phase: NA
status: RECRUITING
sponsor: Kezhong Zhang
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06665113"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06665113"
last_fetched: "2026-05-10T14:08:32.516Z"
source: "Parkinson's Pathways (curated)"
---
# Ear stimulation slows Parkinson progression

**Goal (in five words):** Ear stimulation slows Parkinson progression

**Official Title:** 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

**Trial ID:** [NCT06665113](https://clinicaltrials.gov/study/NCT06665113)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Kezhong Zhang
- **Target Enrollment:** 12 participants
- **Start Date:** 2024-12-23
- **Completion Date:** 2026-06
- **Conditions:** Parkinson Disease, Idiopathic
- **Interventions:** taVNS real stimulation, taVNS sham stimulation
- **Intervention Types:** DEVICE

## Summary For Families

Goal: to find out whether long-term, noninvasive stimulation of the ear branch of the vagus nerve can slow neurodegeneration and protect motor function in early Parkinson's. Approach: the study uses transcutaneous auricular vagus nerve stimulation, a small device that delivers mild electrical pulses to the ear to modulate vagal signaling and related brain circuits, which may reduce neuroinflammation and support dopamine neuron survival; it is randomized and double-blinded with real versus sham stimulation, given alongside each person’s usual Parkinson’s medications without changing levodopa dosing. Eligibility: people 55 to 75 years old with idiopathic Parkinson’s for three years or less and H&Y stage 2.5 or lower at medication start, on standard anti-PD meds, while excluding those with significant cognitive impairment, recent use of certain neuroprotective drugs, prior vagus stimulation, pacemakers or DBS, major heart or MRI contraindications, or a history of falls or freezing.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. Age 55-75 years.
2. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
3. Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation.
4. Parkinson's disease duration ≤ 3 years.
5. Receiving standard anti-Parkinson's disease medication treatment.

Exclusion Criteria:

1. Patients with cognitive impairment (MMSE \< 24 and/or MoCA \< 26) or mental illnesses, or those unable to cooperate for other reasons.
2. 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.
3. 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.
4. Previous treatment with vagus nerve stimulation.
5. 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.
6. 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.
7. 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.
8. Previous history of stroke or intracranial mass lesions.
9. Patients with existing or potential cardiovascular diseases.
10. Ophthalmic diseases affecting eye movements.
11. 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).
12. Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.
13. Concurrent participation in other clinical trials.
14. Inability to receive the required treatment and follow-up due to geographic reasons.
15. Any subject with an upper limb UPDRS tremor score of 3 or higher.
16. Patients with a history of PD-related freezing episodes or falls.
```

## Locations (1)

- The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China _(32.0617, 118.7778)_
  - Kezhong Zhang — (CONTACT) — 13770840575 — kezhong_zhang1969@126.com

## Central Contacts

- Kezhong Zhang, Professor — (CONTACT) — 400-13770840575 — kezhong_zhang1969@126.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT06665113*  
*HTML version: https://parkinsonspathways.com/trial/NCT06665113*  
*Source data: https://clinicaltrials.gov/study/NCT06665113*