taVNS on Functional Mobility in People With DP

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство Sham taVNS
  Physical therapy focusing on functional mobility with sham transcutaneous auricular vagus nerve stimulation.

Первичные конечные точки

• Functional mobility [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]

Вторичные конечные точки (8)

• Balance [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).]
• Balance [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
• Motor function [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
• Motor function [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
• Freezing of gait [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
• Speed of gait [Срок оценки: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
• Patient global impression of change [Срок оценки: Post-intervention (Day 10)]
• Adverse events [Срок оценки: All days of intervention (up to 10 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Universidade Federal de Pernambuco — Recife

Идентификаторы

NCT: NCT07366411 · taVNS_DP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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