taVNS on Functional Mobility in People With DP

Universidade Federal de Pernambuco

Status and phase

Begins enrollment this month

Phase 2

Conditions

PARKINSON DISEASE (Disorder)

Treatments

Device: Sham taVNS

Device: Active taVNS

Study type

Interventional

Funder types

Other

Identifiers

NCT07366411

taVNS_DP

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.