Parkinson's disease
Conditions
Interventions
Participants will initially undergo a clinical screening to collect demographic and health data. Subsequently, eligible participants will be randomized into active transcutaneous auricular vagus nerv
general impairment and disease progression (UPDRS)
quality of life (PDQ-39)
cognitive function (Addenbrooke's Cognitive Examination)
and involuntary movements (Abnormal Involuntary Movements Scale - MSD Manual). Also on the first day, participants will be assessed for heart rate variability and upper limb tremor using an accelerome
functional mobility (Sit and stand test five times)
fine motor function and manual dexterity (Nine pin test)
grip strength (hand dynamometer)
and isokinetic assessment of the bilateral knee and elbow using an isokinetic dynamometer (Biodex 4). After the two-day evaluation, the intervention protocol will begin. The participants will be rando
Sponsors
Universidade Federal de São Carlos
Universidade Federal de São Carlos
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 40-80 years, with a diagnosis confirmed by a neurologist of Parkinson's disease present in stages 1 to 3 of the Hoehn and Yahr scale; who have motor and cognitive complaints related to the Unified Parkinson's Disease Rating Scale (UPDRS) and who have been on stable Parkinson Disease medication for at least 30 days
Exclusion criteria
Exclusion criteria: Individuals with characteristics of other types of parkinsonism; having other health conditions such as musculoskeletal problems, decompensated respiratory or cardiovascular problems, uncontrolled diabetes, uncontrolled systemic arterial hypertension, psychiatric conditions such as dementia diagnosed by a psychiatrist, contraindications for the intervention (implanted cardiac or cranial electronic medical devices, cochlear implant, pacemaker) or conditions in which the principal investigator assesses as not indicated for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the overall function of individuals with Parkinson's disease throught the Unified Parkinson Disease Rating Scale (UPDRS). The result will be assessed by comparing the score in the pre- and post-intervention evaluation. It is expected that there will be no significant difference in most of the items on the assessment tool, with the exception of the motor section | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the cognition throught the Addenbrooke's Cognitive Examination. The result will be evaluated by comparing the score in the pre- and post-intervention evaluation. It is expected that there will be no significant difference in the cognitive capacity of the participants;Evaluate the quality of life through the Parkinson's Disease Questionnarie (PDQ-39). We will analyze the participants' scores on this evaluation instrument pre- and post-intervention. The result will be evaluated by comparing the participants' scores in the pre- and post-intervention evaluation. It is expected that there will be a significant difference in the participants' quality of life as a result of improved motor functions, as previous studies have shown;Evaluate the grip strenght through the manual dynamometer. The outcome will be assessed by comparing the participants' grip strength scores at pre- and post-intervention. It is expected that there will be no significant difference in the participants' grip strength;Evaluate the heart rate variability through the Polar watch. The results will be evaluated by comparing the heart rate variability measurements of the participants in the pre- and post-intervention evaluation. The studies show that the effect of transcutaneous auricular stimulation of the vagus nerve on heart rate variability is inconclusive. Therefore, it is expected that there will be no significant difference in the heart rate variability of the participants;Evaluate the gait speed through the Timed Up and Go test (TUG). We will analyze the participants' gait speed using this test in the pre- and post-intervention. The result will be evaluated by comparing the participants' gait speed measurements in the pre- and post-intervention evaluation. Recent studies have shown that transcutaneous auricular stimulation of the vagus nerve improves different gait variables such as step length, stride velocity, stride length and step length variability. Therefore, transcutaneous auricula | — |
Countries
Brazil
Contacts
Public ContactJose;Anna Prati;Lepesteur Gianlorenço
Universidade Federal de São Carlos;Universidade Federal de São Carlos
Outcome results
None listed