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NOT YET RECRUITING
NCT07366411
PHASE2

taVNS on Functional Mobility in People With DP

Sponsor: Universidade Federal de Pernambuco

View on ClinicalTrials.gov

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.

Official title: Transcutaneous Auricular Vagus Nerve Stimulation on Functional Mobility in People With Parkinson's Disease

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-02-15

Completion Date

2027-06-30

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DEVICE

Active taVNS

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.

DEVICE

Sham taVNS

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

Locations (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil