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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Campus Biomedico
RECRUITING
Roma
Contact Information
Primary
Massimo Marano, MD, PhD
m.marano@policlinicocampus.it
+39 3333488802
Backup
Gaia Anzini, MD
gaia.anzini@unicampus.it
+39 3662007406
Time Frame
Start Date: 2026-02-14
Estimated Completion Date: 2027-10
Participants
Target number of participants: 60
Treatments
Active_comparator: taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT)
Participants will receive active taVNS, stimulation parameters: 25 Hz frequency, 200 μs pulse width, and intensity adjusted to the individual's sensory threshold, delivered to the left auricular tragus for the duration of each session (\~30 minutes). During stimulation, participants will perform treadmill walking on a sensorized treadmill system with simultaneous conventional physical therapy exercises focused on posture, balance, and gait re-education. Sessions will be delivered over a 4-week period, for a total of 10 sessions.
Active_comparator: taVNS paired with conventional physical therapy (cPT)
Participants will receive active taVNS (same parameters and device as Arm 1) during conventional physical therapy sessions without treadmill training.~Sessions will be delivered over a 4-week period, for a total of 10 sessions.
Sham_comparator: Sham taVNS paired with STT and cPT
Sham stimulation will consist of few impulses delivered at 25 Hz for a duration of 60'' before waning, creating the same initial sensation without continuous current delivering.~Participants will simultaneously undergo treadmill-based and conventional physical therapy as described above.~Schedule: 10 sessions will be delivered over a 4-week period.
Sham_comparator: Sham taVNS paired with cPT
Participants will receive sham stimulation (same device and sham procedure as Arm 3) during conventional physical therapy sessions without treadmill training.~Schedule: 10 sessions will be delivered over a 4-week period.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov