taVNS on Functional Mobility in People With DP
Starting soon · Phase 2 · Has a placebo group
Conditions studied: PARKINSON DISEASE (Disorder)
In brief
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.
Key facts
- Study ID
- NCT07366411
- Run by
- Universidade Federal de Pernambuco
- People needed
- 30
- Starts
- 2026-02-15
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-01-26
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Universidade Federal de Pernambuco — Recife, Pernambuco, Brazil
Full record on ClinicalTrials.gov
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