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

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

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.

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.

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).

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

Eligibility

Primary outcome measure(s)

• Evaluation of objective changes in gait speed (m/s) through gait analysis. — Baseline (T0) and Post-intervention (T1, 4 weeks)
  Gait speed (m/s) is measured using a 3D optoelectronic motion-capture system with inertial sensors during level walking on a 10-meter walkway with integrated force platforms. Standard lower-limb reflective markers and surface EMG are used to capture kinematic and muscle-activation patterns. Average gait speed is calculated as the mean forward velocity.

Trial sites (1)

More Fondazione Policlinico Universitario Campus Bio-Medico trials in Italy