Idiopathic Parkinson's Disease (PD)AVANTGARDE-PDNCT07337226
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physical Therapy (cPT) and Sensorized Treadmill Training (STT) in people with Idiopathic Parkinson's Disease (PD), run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease (PD)
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physical Therapy (cPT) and Sensorized Treadmill Training (STT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Campus Biomedico
Roma, RM, 00128
Massimo Marano, MD, PhD, + 393333488802, m.marano@policlinicocampus.it
Gaia Anzini, MD, +393662007406, gaia.anzini@unicampus.it
About this study
Official title: Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)
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:
Read more
- 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
Read the detailed description
Parkinson's disease (PD) is characterized by gait disturbance, impaired mobility, and progressive involvement of neural circuits responsible for locomotion and postural control. Although physical therapy is effective, its benefits are often modest and short-lived. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that activates the auricular branch of the vagus nerve and engages ascending brainstem pathways involved in motor control, arousal regulation, and inflammatory modulation. Previous studies have shown that taVNS can influence subcortical β-band oscillations, improve gait parameters, enhance cognitive performance, and modulate systemic inflammatory markers in individuals with PD.
This randomized, double-blind, sham-controlled clinical trial evaluates whether pairing taVNS with gait-focused rehabilitation enhances motor outcomes and neural plasticity in individuals with de novo PD. Participants are newly diagnosed (≤6 months) and undergo a 4-week rehabilitation program consisting of conventional physiotherapy, with or without sensorized treadmill training. Active or sham taVNS is administered during each therapy session. The study includes four parallel arms to independently assess the contributions of taVNS and treadmill-based gait training.
Outcomes are assessed at baseline (T0), immediately post-intervention (T1), and at a 4-week follow-up visit (T2). Primary and secondary outcomes include quantitative gait parameters, clinical motor scales, cognitive performance, and quality-of-life measures. Exploratory outcomes include changes in cerebral blood flow measured with pseudo-continuous arterial spin labeling (PCASL), functional connectivity during a simulated gait task using fMRI, and blood and salivary biomarkers of inflammation and neurodegeneration (e.g., TNF-α, interleukins, and α-synuclein).
The study aims to determine whether taVNS enhances rehabilitation-induced improvements in gait, whether these benefits persist beyond the treatment period, and whether taVNS induces measurable changes in brain perfusion, functional networks, or circulating biological markers relevant to PD pathophysiology. Results may support the development of a scalable, non-invasive therapeutic approach that can be integrated into early PD management.
- Conditions
- Idiopathic Parkinson's Disease (PD)
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Conventional Physical Therapy (cPT), Sensorized Treadmill Training (STT)
- Keywords
- Parkinson's disease, Vagus nerve stimulation, non invasive brain stimulation, treadmill training, freezing of gait, rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Procedure or surgery
Also called Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, nVNS, tVNS
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)Procedure or surgery
Also called Sham transcutaneous auricular vagus nerve stimulation, sham taVNS, sham
Sham taVNS using the electrode placement as active taVNS but without electrical stimulation beyond the initial sensation.
Conventional Physical Therapy (cPT)Other
Also called 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)Other
Also called Sensorized Treadmill Training, STT, treadmill, sensorized treadmill
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 group | Role | What they receive |
|---|---|---|
| taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT) | Active comparator | 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. Receives: Procedure: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Conventional Physical Therapy (cPT); Other: Sensorized Treadmill Training (STT) |
| taVNS paired with conventional physical therapy (cPT) | Active comparator | 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. Receives: Procedure: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Conventional Physical Therapy (cPT) |
| Sham taVNS paired with STT and cPT | Sham comparator | 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. Receives: Procedure: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS); Other: Conventional Physical Therapy (cPT); Other: Sensorized Treadmill Training (STT) |
| Sham taVNS paired with cPT | Sham comparator | 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. Receives: Procedure: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS); Other: Conventional Physical Therapy (cPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of objective changes in gait speed (m/s) through gait analysis.
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.
Measured: Baseline (T0) and Post-intervention (T1, 4 weeks)
Secondary outcomes (11)
Spatiotemporal and Kinematic Gait Parameters assessment (gait quality parameter).
Spatiotemporal and kinematic gait parameters are measured using a 3D motion-capture system with inertial sensors and surface EMG while participants walk across a walkway with integrated force platforms. Parameters include stance and swing phase duration (s), single and double support time (s), step and stride length (cm) and variability (%), swing speed (m/s) and cadence (steps/min), lower-limb joint flexion-extension angles (°), peak vertical ground reaction force (N/kg), and muscle-activation timing (ms) from surface EMG. All listed parameters will be analyzed collectively as a single composite secondary outcome and will not be reported as separate outcome measures.
Measured: Baseline (T0), Post-intervention at 4 weeks (T1)
Change in Motor Function (MDS-UPDRS Part III Total Score).
Motor function will be assessed using the Movement Disorder Society Unified Parkinson's Disease Rating Scale, Part III (MDS-UPDRS III), which evaluates bradykinesia, rigidity, tremor, posture, and gait-related motor signs. Total scores range from 0 to 132, with higher scores indicating worse motor impairment. Improvement is reflected by a decrease in the MDS-UPDRS III score.
Measured: Baseline (T0) and Post-intervention at 4 weeks (T1).
Cognitive Function (MoCA Total Score) assessment
Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool designed to detect mild cognitive impairment. The MoCA evaluates multiple cognitive domains including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline (T0) and Post-intervention at 4 weeks (T1)
Quality of Life (PDQ-39 Total and Domain Scores) assessment.
Quality of life is assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39), which measures mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Domain and total scores range from 0 to 100, with higher scores indicating poorer quality of life. Improvement is reflected by a decrease in PDQ-39 scores.
Measured: Baseline (T0) and Post-intervention at 4 weeks (T1)
Change in Gait Speed from Post-intervention to Follow-up.
Average gait speed (m/s) is measured using a 3D motion-capture system during level walking. This outcome represents the change in gait speed between the post-intervention visit (T1) and the follow-up visit (T2) to evaluate persistence of treatment effects.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Spatiotemporal and Kinematic Gait Parameters (gait quality parameter) from Post-intervention to Follow-up.
Spatiotemporal and kinematic gait parameters (stance and swing duration (s), single and double support time (s), step and stride length (cm) and variability (%), swing speed (cm/s) and cadence (steps/min), joint flexion-extension angles (°), peak vertical ground reaction force (N/kg), and muscle-activation timing (ms)) are assessed with 3D motion capture, force platforms, and surface EMG. All listed parameters will be analyzed collectively as a single composite secondary outcome and will not be reported as separate outcome measures. This outcome reflects change in these parameters from T1 to T2.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Motor Function (MDS-UPDRS Part III Total Score) from Post-intervention to Follow-up.
Motor function will be assessed using the Movement Disorder Society Unified Parkinson's Disease Rating Scale, Part III (MDS-UPDRS III), which evaluates bradykinesia, rigidity, tremor, posture, and gait-related motor signs. Total scores range from 0 to 132, with higher scores indicating worse motor impairment. Improvement is reflected by a decrease in the MDS-UPDRS III score.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Cognitive Function (MoCA Total Score) from Post-intervention to Follow-up
Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool for the detection of mild cognitive impairment. The MoCA evaluates multiple cognitive domains including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. This outcome captures the change in MoCA total score from post-intervention (T1) to follow-up (T2) to evaluate the persistence of cognitive effects over time. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Quality of Life (PDQ-39) from Post-intervention to Follow-up.
Quality of life is assessed using the PDQ-39, which measures mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. This outcome represents the change in PDQ-39 total score from T1 to T2, where higher scores indicate poorer quality of life and improvement is reflected by a decrease in scores.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Inflammatory Biomarkers (Serum and Salivary Cytokines) from Post-intervention to Follow-up.
Serum and salivary levels of inflammatory cytokines (TNF-α, IL-1β, IL-13, IL-10, IL-6) will be measured using standardized ELISA or multiplex immunoassays. Concentrations will be expressed in pg/mL. Cytokines will be analyzed collectively as a composite inflammatory outcome.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Neurodegenerative Biomarker Levels (α-Synuclein) from Post-intervention to Follow-up.
Serum and salivary levels of α-synuclein will be measured using standardized immunoassays. Concentrations will be expressed in ng/mL.
Measured: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start14 Feb 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Marano, Fondazione Policlinico Universitario Campus Bio-Medico
- Investigators
- Massimo Marano, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337226
- Sponsor's protocol ID
- AVANTGARDE-PD
- Acronym
- AVANTGARDE-PD
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared due to privacy reasons
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)
- ClinicalTrials.gov ID
- NCT07337226
- Acronym / sponsor ID
- AVANTGARDE-PD / AVANTGARDE-PD
- Conditions
- Idiopathic Parkinson's Disease (PD)
- Keywords
- Parkinson's disease, Vagus nerve stimulation, non invasive brain stimulation, treadmill training, freezing of gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Parkinson's disease (PD) is characterized by gait disturbance, impaired mobility, and progressive involvement of neural circuits responsible for locomotion and postural control. Although physical therapy is effective, its benefits are often modest and short-lived. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that activates the auricular branch of the vagus nerve and engages ascending brainstem pathways involved in motor control, arousal regulation, and inflammatory modulation. Previous studies have shown that taVNS can influence subcortical β-band oscillations, improve gait parameters, enhance cognitive performance, and modulate systemic inflammatory markers in individuals with PD.
This randomized, double-blind, sham-controlled clinical trial evaluates whether pairing taVNS with gait-focused rehabilitation enhances motor outcomes and neural plasticity in individuals with de novo PD. Participants are newly diagnosed (≤6 months) and undergo a 4-week rehabilitation program consisting of conventional physiotherapy, with or without sensorized treadmill training. Active or sham taVNS is administered during each therapy session. The study includes four parallel arms to independently assess the contributions of taVNS and treadmill-based gait training.
Outcomes are assessed at baseline (T0), immediately post-intervention (T1), and at a 4-week follow-up visit (T2). Primary and secondary outcomes include quantitative gait parameters, clinical motor scales, cognitive performance, and quality-of-life measures. Exploratory outcomes include changes in cerebral blood flow measured with pseudo-continuous arterial spin labeling (PCASL), functional connectivity during a simulated gait task using fMRI, and blood and salivary biomarkers of inflammation and neurodegeneration (e.g., TNF-α, interleukins, and α-synuclein).
The study aims to determine whether taVNS enhances rehabilitation-induced improvements in gait, whether these benefits persist beyond the treatment period, and whether taVNS induces measurable changes in brain perfusion, functional networks, or circulating biological markers relevant to PD pathophysiology. Results may support the development of a scalable, non-invasive therapeutic approach that can be integrated into early PD management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT) | Active comparator | Procedure: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Other: Conventional Physical Therapy (cPT), Other: Sensorized Treadmill Training (STT)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. |
| taVNS paired with conventional physical therapy (cPT) | Active comparator | Procedure: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Other: 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 taVNS paired with STT and cPT | Sham comparator | Procedure: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Other: Conventional Physical Therapy (cPT), Other: Sensorized Treadmill Training (STT)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 taVNS paired with cPT | Sham comparator | Procedure: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Other: Conventional Physical Therapy (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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Also: Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, nVNS, tVNSActive taVNS delivered at the inner tragus of the left ear (25 Hz, 200 μs, intensity at sensory threshold) | Procedure or surgery | taVNS paired with conventional physical therapy (cPT), taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT) |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)Also: Sham transcutaneous auricular vagus nerve stimulation, sham taVNS, shamSham taVNS using the electrode placement as active taVNS but without electrical stimulation beyond the initial sensation. | Procedure or surgery | Sham taVNS paired with STT and cPT, Sham taVNS paired with cPT |
| Conventional Physical Therapy (cPT)Also: Conventional Physical Therapy, cPTConventional Physical Therapy delivered to all groups consist of exercises aimed at posture alignment, reduction of hypertone, balance improvement and overground gait training. | Other | Sham taVNS paired with STT and cPT, Sham taVNS paired with cPT, taVNS paired with conventional physical therapy (cPT), taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT) |
| Sensorized Treadmill Training (STT)Also: Sensorized Treadmill Training, STT, treadmill, sensorized treadmillSensorized 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). | Other | Sham taVNS paired with STT and cPT, taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT) |
Primary outcome
Evaluation of objective changes in gait speed (m/s) through gait analysis.
Time frame: 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.
11 secondary outcomes
Spatiotemporal and Kinematic Gait Parameters assessment (gait quality parameter).
Time frame: Baseline (T0), Post-intervention at 4 weeks (T1)
Change in Motor Function (MDS-UPDRS Part III Total Score).
Time frame: Baseline (T0) and Post-intervention at 4 weeks (T1).
Cognitive Function (MoCA Total Score) assessment
Time frame: Baseline (T0) and Post-intervention at 4 weeks (T1)
Quality of Life (PDQ-39 Total and Domain Scores) assessment.
Time frame: Baseline (T0) and Post-intervention at 4 weeks (T1)
Change in Gait Speed from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Spatiotemporal and Kinematic Gait Parameters (gait quality parameter) from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Motor Function (MDS-UPDRS Part III Total Score) from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Cognitive Function (MoCA Total Score) from Post-intervention to Follow-up
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Quality of Life (PDQ-39) from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Inflammatory Biomarkers (Serum and Salivary Cytokines) from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Change in Neurodegenerative Biomarker Levels (α-Synuclein) from Post-intervention to Follow-up.
Time frame: Post-intervention at 4 weeks (T1) and Follow-up at 8 weeks (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. Not shared due to privacy reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Marano, MD, PhD principal investigator
Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physical Therapy (cPT) and Sensorized Treadmill Training (STT) in people with Idiopathic Parkinson's Disease (PD), run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Marano, MD, PhD (+39 3333488802, m.marano@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of objective changes in gait speed (m/s) through gait analysis. (time frame: Baseline (T0) and Post-intervention (T1, 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.