TaVNS with gait training for newly diagnosed Parkinson’s patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study compares active taVNS to sham stimulation during four weeks of gait-focused rehabilitation in people with idiopathic Parkinson’s disease diagnosed within the last six months. Participants receive either taVNS with conventional physical therapy or sham taVNS during each of 12 sessions, with additional assessment of gait, brain activity, and inflammatory markers. The study also examines whether taVNS paired with therapy enhances neural plasticity and movement-related brain perfusion. Outcomes are measured at baseline, immediately after the four-week program, and at a four-week follow-up. Four parallel arms evaluate the separate and combined effects of taVNS and treadmill-based training.

Why it matters

Who can join: the full rules

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.

Where it's running

• Campus Biomedico
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Massimo Marano, MD, PhD — Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
• Study coordinator: Massimo Marano, MD, PhD
• Email: m.marano@policlinicocampus.it
• Phone: +39 3333488802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.