taVNS on Functional Mobility in People With DP

NCT07366411 | Not Yet Recruiting Phase 2

• 1 other identifier: taVNS_DP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)

Secondary Outcomes (8)

• Balance

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).

• Balance

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)

• Motor function

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)

• Motor function

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)

• Freezing of gait

  Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)

Study Arms (2)

Active transcutaneous auricular vagus nerve stimulation

ACTIVE COMPARATOR

Device: Active taVNS

Sham transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

Device: Sham taVNS

Interventions

Active taVNS DEVICE

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.

Active transcutaneous auricular vagus nerve stimulation

Sham taVNS DEVICE

Physical therapy focusing on functional mobility with sham transcutaneous auricular vagus nerve stimulation.

Sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kátia Monte-Silva, Phd in neurosciences

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

João Victor Fabrício Vieira de Melo, Phd Student

CONTACT

+5581986450112; joaovmelo2015@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 26, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)