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Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease

NCT07337226 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) can improve gait and brain function in people with diagnosis of idiopathic Parkinson's disease (PD) within 6 months. It will also help researchers learn about the safety and biological effects of taVNS when used together with physical therapy.

The main questions it aims to answer are:

* Does taVNS paired with physical therapy improve walking speed and gait performance in people with PD?
* Does taVNS change brain activity or breain perfusion related to movement?
* Does taVNS reduce markers of inflammation and neurodegeneration in blood and saliva? Researchers will compare active taVNS to sham (placebo) stimulation to see if active taVNS works better when paired with physical therapy.

Participants will:

* Attend 12 rehabilitation sessions over 4 weeks (three per week)
* Receive either active or sham taVNS during each session while doing treadmill and conventional physical therapy
* Undergo gait and cognitive testing, MRI scans, and blood and saliva collection before and after treatment
* Return for a follow-up visit four weeks after therapy to check how long the effects last

Conditions

  • Idiopathic Parkinson's Disease (PD)

Interventions

PROCEDURE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Active taVNS delivered at the inner tragus of the left ear (25 Hz, 200 μs, intensity at sensory threshold)

PROCEDURE

Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)

Sham taVNS using the electrode placement as active taVNS but without electrical stimulation beyond the initial sensation.

OTHER

Conventional Physical Therapy (cPT)

Conventional Physical Therapy delivered to all groups consist of exercises aimed at posture alignment, reduction of hypertone, balance improvement and overground gait training.

OTHER

Sensorized Treadmill Training (STT)

Sensorized Treadmill Training consist of a sensorized gait treadmill training with continuous visual feedback combined with dual cognitive tasks (e.g. repeat digits, repeat sequence of words, counting down the dates).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Principal Investigators

  • Massimo Marano, MD, PhD · Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337226 on ClinicalTrials.gov