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Not yet recruiting NCT07366411

taVNS on Functional Mobility in People With DP

Phase II Interventional PARKINSON DISEASE (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active taVNS, Sham taVNS.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Functional mobility [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
Secondary outcome measures (8)
  • Balance [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).]
  • Balance [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
  • Motor function [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
  • Motor function [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
  • Freezing of gait [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
  • Speed of gait [Time frame: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)]
  • Patient global impression of change [Time frame: Post-intervention (Day 10)]
  • Adverse events [Time frame: All days of intervention (up to 10 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Universidade Federal de Pernambuco — Recife

Identifiers

NCT: NCT07366411 · taVNS_DP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗