---
title: Ear stimulation improves walking speed
nct_id: NCT07337226
acronym: AVANTGARDE-PD
phase: NA
status: RECRUITING
sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07337226"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07337226"
last_fetched: "2026-07-16T14:01:56.641Z"
source: "Parkinson's Pathways (curated)"
---
# Ear stimulation improves walking speed

**Goal (in five words):** Ear stimulation improves walking speed

**Official Title:** Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)

**Study Acronym:** AVANTGARDE-PD

**Trial ID:** [NCT07337226](https://clinicaltrials.gov/study/NCT07337226)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Fondazione Policlinico Universitario Campus Bio-Medico
- **Target Enrollment:** 60 participants
- **Start Date:** 2026-02-14
- **Completion Date:** 2027-10
- **Conditions:** Idiopathic Parkinson's Disease (PD)
- **Interventions:** Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Conventional Physical Therapy (cPT), Sensorized Treadmill Training (STT)
- **Intervention Types:** PROCEDURE, OTHER

## Summary For Families

The study is testing whether non-invasive ear stimulation that targets the vagus nerve can improve walking and brain function in people recently diagnosed with Parkinson's, and whether it is safe and produces measurable biological effects when added to physical therapy. Participants get either active or placebo ear stimulation while doing treadmill and conventional physical therapy across 12 sessions over 4 weeks, and researchers will measure walking speed and gait, brain scans of activity and blood flow, and blood and saliva markers of inflammation and neurodegeneration. This stimulation activates the ear branch of the vagus nerve and engages brainstem pathways involved in movement, alertness, and inflammation; previous work has shown it can affect brain rhythms, gait, thinking, and inflammatory markers. The trial is looking for people aged 50 to 80 who were diagnosed within the last 6 months, can walk at least 10 meters alone, have a mental status test score above 24, have been on stable therapy for at least a month, and are not on high levodopa-equivalent doses or have ear or magnetic resonance imaging contraindications.

## What This Actually Involves

**Placebo** _(From the protocol)_: This trial has 4 groups, and 2 are sham (a pretend version of the procedure) groups. Because assignment is random, you have about a 2 in 4 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.

**Visits** _(From the protocol)_: You will attend 12 rehabilitation sessions over 4 weeks (three per week).
  > "* Attend 12 rehabilitation sessions over 4 weeks (three per week)"

**Procedures** _(From the protocol)_:
- MRI scan (Non-invasive)
  > "* Undergo gait and cognitive testing, MRI scans, and blood and saliva collection before and after treatment"
- Thinking & memory tests (Non-invasive)
  > "* Undergo gait and cognitive testing, MRI scans, and blood and saliva collection before and after treatment"

**Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long.

**Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered.

_Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Idiopathic PD diagnosis within 6 months, confirmed by neurologist specialized in Parkinson's disease and movement disorders;
* Ability to walking independently for at least 10 meters unassisted;
* Age included between 50 and 80;
* MMSE \> 24;
* On stable therapy for at least 1 month prior to the experiment.

Exclusion Criteria:

* Clinical and radiological red flags for atypical, vascular parkinsonism or alternative diagnosis (e.g., normal pressure hydrocephalus);
* Levodopa equivalent daily dose \> 300 mg;
* Any contraindication for taVNS (e.g., ear lesions, auditory prosthesis)
* Any contraindication for MRI (e.g., non compatible pacemakers or prosthesis, claustrophobic subjects);
* Concomitant neurological, orthopedic or active medical/oncological condition that would affect participating to the study;
* Attempting to other neurorehabilitation programs within 3 months.
```

## Locations (1)

- Campus Biomedico, Roma, RM, Italy _(44.9936, 11.1064)_
  - Massimo Marano, MD, PhD, (CONTACT), + 393333488802, m.marano@policlinicocampus.it
  - Gaia Anzini, MD, (CONTACT), +393662007406, gaia.anzini@unicampus.it

## Central Contacts

- Massimo Marano, MD, PhD, (CONTACT), +39 3333488802, m.marano@policlinicocampus.it
- Gaia Anzini, MD, (CONTACT), +39 3662007406, gaia.anzini@unicampus.it

---

*Canonical: https://parkinsonspathways.com/trial/NCT07337226*  
*HTML version: https://parkinsonspathways.com/trial/NCT07337226*  
*Source data: https://clinicaltrials.gov/study/NCT07337226*