PARKINSON DISEASE (Disorder)Phase 2NCT07366411
taVNS on Functional Mobility in People With DP
A Phase 2 study testing Active taVNS in people with PARKINSON DISEASE (Disorder), run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Parkinson's disease (PD) is characterized by motor impairments such as bradykinesia accompanied by resting tremor and/or rigidity. As PD progresses due to its neurodegenerative nature, complementary strategies must be developed to optimize its effects. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2026to 30 Jun 2027
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of PD provided by a neurologist;
- undergoing regular antiparkinsonian drug treatment (at least three months of regular and stable use);
- aged 40 years or older;
- with a Hoehn \& Yahr stage of 2.5 to 4.
Who cannot join
- other neurological disorders, postural hypotension, vestibular, musculoskeletal, or visual disorders that compromise performance in the proposed tests;
- other osteomyoarticular diseases in the lower limbs that interfere with performance and locomotion;
- Montreal Cognitive Assessment (MoCA) score lower than 21 points;
- previous surgical procedure for PD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
João Fabrício, Phd Student, +5581986450112, joaovmelo2015@gmail.com
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation on Functional Mobility in People With Parkinson's Disease
Parkinson's disease (PD) is characterized by motor impairments such as bradykinesia accompanied by resting tremor and/or rigidity. As PD progresses due to its neurodegenerative nature, complementary strategies must be developed to optimize its effects. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a strategy for controlling the symptoms of the disease. Nevertheless, the efficacy of this approach in managing PD remains to be elucidated. The objective of the present study is to investigate and compare the effects of transcutaneous vagus nerve stimulation (taVNS) and sham taVNS on functional mobility, which is the primary outcome and will be assessed using the Timed Up and Go test. The following tests will be used to evaluate the secondary outcomes: the miniBESTest and the Biodex Balance System (balance), the MDS-UPDRS and the Five-Time Sit-to-Stand Test (motor function), the FOG-Q (freezing of gait), the 10-Meter Walk Test (gait speed), the PGIC (perception of change), and the recording of adverse events. The volunteers will be divided into two groups: one group will receive taVNS in conjunction with physical therapy, while the other group will receive a sham taVNS in conjunction with physical therapy. To assess the effect of therapy, the efficacy of taVNS in enhancing the effects of physical therapy on the functional mobility of people with PD will be evaluated.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Active taVNS, Sham taVNS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
taVNS will be applied to the concha in the left auricle of volunteers with the following parameters: 8 trains of 120 seconds of stimulation each at 25 Hz, 300 μs, and 60 seconds of interstimulus interval, with intensity below the pain threshold, totaling 24 minutes of stimulation. The stimulation is combined with physical therapy focused on functional mobility.
Sham taVNSDevice
Physical therapy focusing on functional mobility with sham transcutaneous auricular vagus nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active transcutaneous auricular vagus nerve stimulation | Active comparator | Not described Receives: Device: Active taVNS |
| Sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Not described Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test. In the TUG, the time taken by the volunteer to perform the activity of getting up from a chair, walking, and sitting back down is timed. The test begins with the volunteer sitting in a chair with their back against the backrest; when asked, they stand up, walk three meters at their fastest speed, but safely, turn around, return to the chair, and sit down. Shorter times in performing this test translate into greater functional mobility. Three repetitions of the test will be scored, and for analysis purposes, the average of the repetitions will be used.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Secondary outcomes (8)
Balance
Static and dynamic balance will be assessed using the reduced version of the Balance Evaluation System Test (miniBESTest), which aims to evaluate six different balance control mechanisms based on 14 specific activities of daily living. Each activity is scored from 0 (worst performance) to 2 (best performance). Thus, lower scores indicate poorer balance.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).
Balance
The Biodex Balance System (BBS) will be used, which is a mobile platform with levels of instability. In the present study, the postural stability test will be used, starting from level 12 towards level 8. That is, from greater to lesser stability. At the end of the test, the BBS provides three data points: anterior-posterior displacement index (API), medial-lateral displacement index (MLI), and overall stability index (OSI).
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Motor function
Motor function will be assessed using the Five Times Sit-to-Stand Test (FTSST) and sections II and III of the Movement Disorder Society Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). In the FTSST, volunteers are asked to stand up and sit down five times as quickly as possible, but safely. Shorter times on this test indicate greater functional mobility. For analysis purposes, the average of three repetitions of this test will be used.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Motor function
The MDS-UPDRS is the most widely used clinical assessment tool for characterizing the motor symptoms of PD and for monitoring the progression of these symptoms and the physical disability caused by the disease. The MDS-UPDRS consists of 50 items scored from 0 to 4 each, from best (0) to worst motor performance (4), and is widely accepted for determining the effectiveness of intervention in clinical studies.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Freezing of gait
Freezing of gait is assessed using the Freezing of Gait Questionnaire (FOG-Q), which consists of a scale that measures the volunteer's subjective perception of the severity and impact of freezing during gait. The FOG-Q has six items, each scored from 0 to 4, for a total of 24 points. A higher score indicates that gait performance is more affected by freezing.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Speed of gait
Walking speed will be assessed using the 10-meter walk test (10MWT), in which the volunteer is instructed to walk down a 10-meter corridor. The test begins with the volunteer standing, and after instruction, they must walk the 10-meter course and stop at the end of it. Two repetitions of the test will be performed, the first with the volunteer walking at their comfortable speed and the second at their fastest speed, but safely.
Measured: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Patient global impression of change
The perception of improvement will be verified through the Patient Global Impression of Change (PGIC). This aims to quantify the volunteer's perception of improvement for the proposed treatment in relation to activities of daily living, disease symptoms, emotions, and quality of life. Volunteers are given seven response options, ranging from "no change or condition worsened" to "much better, with a considerable improvement that made all the difference." This questionnaire will only be administered at the end of the ten sessions.
Measured: Post-intervention (Day 10)
Adverse events
Adverse events will be assessed based on the volunteer's report. The most common adverse effects are headache, tingling in the electrode region, burning sensation, and drowsiness. For each sensation, the volunteer will rate its intensity on a Likert scale ranging from 0 (none) to 4 (strong).
Measured: All days of intervention (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, Phd in neurosciences, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366411
- Sponsor's protocol ID
- taVNS_DP
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation on Functional Mobility in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07366411
- Acronym / sponsor ID
- taVNS_DP
- Conditions
- PARKINSON DISEASE (Disorder)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 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.
Parkinson's disease (PD) is characterized by motor impairments such as bradykinesia accompanied by resting tremor and/or rigidity. As PD progresses due to its neurodegenerative nature, complementary strategies must be developed to optimize its effects. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a strategy for controlling the symptoms of the disease. Nevertheless, the efficacy of this approach in managing PD remains to be elucidated. The objective of the present study is to investigate and compare the effects of transcutaneous vagus nerve stimulation (taVNS) and sham taVNS on functional mobility, which is the primary outcome and will be assessed using the Timed Up and Go test. The following tests will be used to evaluate the secondary outcomes: the miniBESTest and the Biodex Balance System (balance), the MDS-UPDRS and the Five-Time Sit-to-Stand Test (motor function), the FOG-Q (freezing of gait), the 10-Meter Walk Test (gait speed), the PGIC (perception of change), and the recording of adverse events. The volunteers will be divided into two groups: one group will receive taVNS in conjunction with physical therapy, while the other group will receive a sham taVNS in conjunction with physical therapy. To assess the effect of therapy, the efficacy of taVNS in enhancing the effects of physical therapy on the functional mobility of people with PD will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous auricular vagus nerve stimulation | Active comparator | Device: Active taVNS |
| Sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Sham taVNS |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of PD provided by a neurologist;
- undergoing regular antiparkinsonian drug treatment (at least three months of regular and stable use);
- aged 40 years or older;
- with a Hoehn \& Yahr stage of 2.5 to 4.
Key exclusion criteria (4 listed)
- other neurological disorders, postural hypotension, vestibular, musculoskeletal, or visual disorders that compromise performance in the proposed tests;
- other osteomyoarticular diseases in the lower limbs that interfere with performance and locomotion;
- Montreal Cognitive Assessment (MoCA) score lower than 21 points;
- previous surgical procedure for PD.
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 |
|---|---|---|
| Active taVNStaVNS will be applied to the concha in the left auricle of volunteers with the following parameters: 8 trains of 120 seconds of stimulation each at 25 Hz, 300 μs, and 60 seconds of interstimulus interval, with intensity below the pain threshold, totaling 24 minutes of stimulation. The stimulation is combined with physical therapy focused on functional mobility. | Device | Active transcutaneous auricular vagus nerve stimulation |
| Sham taVNSPhysical therapy focusing on functional mobility with sham transcutaneous auricular vagus nerve stimulation. | Device | Sham transcutaneous auricular vagus nerve stimulation |
Primary outcome
Functional mobility
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. In the TUG, the time taken by the volunteer to perform the activity of getting up from a chair, walking, and sitting back down is timed. The test begins with the volunteer sitting in a chair with their back against the backrest; when asked, they stand up, walk three meters at their fastest speed, but safely, turn around, return to the chair, and sit down. Shorter times in performing this test translate into greater functional mobility. Three repetitions of the test will be scored, and for analysis purposes, the average of the repetitions will be used.
8 secondary outcomes
Balance
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).
Balance
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Motor function
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Motor function
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Freezing of gait
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Speed of gait
Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Patient global impression of change
Time frame: Post-intervention (Day 10)
Adverse events
Time frame: All days of intervention (up to 10 days)
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 26 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for PARKINSON DISEASE (Disorder)
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
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.
Kátia Monte-Silva, Phd in neurosciences study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active taVNS in people with PARKINSON DISEASE (Disorder), run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Jan 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 João Victor Fabrício Vieira de Melo, Phd Student (+5581986450112, joaovmelo2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional mobility (time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)). 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 26 Jan 2026.