PARKINSON DISEASE (Disorder)
Conditions
Brief 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.
Interventions
DEVICEActive 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.
DEVICESham taVNS
Physical therapy focusing on functional mobility with sham transcutaneous auricular vagus nerve stimulation.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional mobility | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30) | Functional mobility will be assessed using the Timed Up and Go (TUG) test. In the TUG, the time taken by the volunteer to perform the activity of getting up from a chair, walking, and sitting back down is timed. The test begins with the volunteer sitting in a chair with their back against the backrest; when asked, they stand up, walk three meters at their fastest speed, but safely, turn around, return to the chair, and sit down. Shorter times in performing this test translate into greater functional mobility. Three repetitions of the test will be scored, and for analysis purposes, the average of the repetitions will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30). | Static and dynamic balance will be assessed using the reduced version of the Balance Evaluation System Test (miniBESTest), which aims to evaluate six different balance control mechanisms based on 14 specific activities of daily living. Each activity is scored from 0 (worst performance) to 2 (best performance). Thus, lower scores indicate poorer balance. |
| Motor function | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30) | Motor function will be assessed using the Five Times Sit-to-Stand Test (FTSST) and sections II and III of the Movement Disorder Society Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). In the FTSST, volunteers are asked to stand up and sit down five times as quickly as possible, but safely. Shorter times on this test indicate greater functional mobility. For analysis purposes, the average of three repetitions of this test will be used. |
| Freezing of gait | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30) | Freezing of gait is assessed using the Freezing of Gait Questionnaire (FOG-Q), which consists of a scale that measures the volunteer's subjective perception of the severity and impact of freezing during gait. The FOG-Q has six items, each scored from 0 to 4, for a total of 24 points. A higher score indicates that gait performance is more affected by freezing. |
| Speed of gait | Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30) | Walking speed will be assessed using the 10-meter walk test (10MWT), in which the volunteer is instructed to walk down a 10-meter corridor. The test begins with the volunteer standing, and after instruction, they must walk the 10-meter course and stop at the end of it. Two repetitions of the test will be performed, the first with the volunteer walking at their comfortable speed and the second at their fastest speed, but safely. |
| Patient global impression of change | Post-intervention (Day 10) | The perception of improvement will be verified through the Patient Global Impression of Change (PGIC). This aims to quantify the volunteer's perception of improvement for the proposed treatment in relation to activities of daily living, disease symptoms, emotions, and quality of life. Volunteers are given seven response options, ranging from "no change or condition worsened" to "much better, with a considerable improvement that made all the difference." This questionnaire will only be administered at the end of the ten sessions. |
| Adverse events | All days of intervention (up to 10 days) | Adverse events will be assessed based on the volunteer's report. The most common adverse effects are headache, tingling in the electrode region, burning sensation, and drowsiness. For each sensation, the volunteer will rate its intensity on a Likert scale ranging from 0 (none) to 4 (strong). |
Countries
Brazil
Contacts
CONTACTJoão Victor Fabrício Vieira de Melo, Phd Student
STUDY_DIRECTORKátia Monte-Silva, Phd in neurosciences
Universidade Federal de Pernambuco
Outcome results
None listed