Parkinson Disease Neurological Gait Disorders
Conditions
Interventions
This is a randomized, controlled, four-arm clinical trial, without blinding. Participants will be allocated to one of the intervention groups with non-invasive cortical electrical stimulation (ANODE o
Har scale (1-3) of Parkinson&apos
s Disease. The current intensity of the transcranial stimulator will be configured according to the tolerance and safety limits of the technique, in this case, 2 mA. Randomization will be in blocks: p
the intervention will take place over a period of 10 days. All volunteers must be off medication at the time of the intervention. The experimental design basically consists of collecting outcome measu
Sponsors
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro (UERJ)
Universidade do Estado do Rio de Janeiro
Eligibility
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: -Volunteer with Parkinson Disease of either sex; - aged 30 to 60 years; - clinically confirmed diagnosis of idiopathic Parkinson's Disease, according to the criteria of "The International Parkinson and Movement Disorder Society" (MDS); - with stages 1 to 3 on the Hoehn & Yahr scale (mild to moderate disease); - stable medication use for at least 4 weeks and no anticipated medication change during the protocol
Exclusion criteria
Exclusion criteria: -Volunteers without other associated neurological and psychiatric diseases that could interfere with the intervention and/or with the collection and analysis of data; - intracranial implants or electronic devices; - history of cranial fracture or cranioencephalic anatomical abnormality; - history of epilepsy; - severe cognitive impairment that prevents understanding of the procedures; - dermatological lesions in the area of ??electrode application
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that some statistical power will be found through the analysis of the data that can validate our hypothesis over a period of 2 years, verification will be through the variation in the MDS-UPDRS Part III score (motor examination), calculated as the difference between the post-intervention and pre-intervention values, we will observe using a paired t-test if the distribution of differences meets the assumptions of normality, or, alternatively, by the non-parametric Wilcoxon test for paired samples when such assumptions are not met. Additionally, a descriptive analysis of the magnitude of the effect will be performed, including the mean of the variation, 95% confidence interval, and effect size (Cohen's d for paired measures). The interpretation of the results will consider as a reference the minimum clinically important difference (MCID) for the MDS-UPDRS Part III, adopted as approximately 5 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that some statistical power will be found through the analysis of the data that can validate our hypothesis over a period of 2 years, verification will be through the variation in the MDS-UPDRS Part III score (motor examination), calculated as the difference between the post-intervention and pre-intervention values, we will observe using a paired t-test if the distribution of differences meets the assumptions of normality, or, alternatively, by the non-parametric Wilcoxon test for paired samples when such assumptions are not met. Additionally, a descriptive analysis of the magnitude of the effect will be performed, including the mean of the variation, 95% confidence interval, and effect size (Cohen's d for paired measures). The interpretation of the results will consider as a reference the minimum clinically important difference (MCID) for the MDS-UPDRS Part III, adopted as approximately 5 points.;It is expected that some statistical power will be found through the analysis of the data that can validate our objective over a period of 2 years;in the case of accelerometry verification, derived variables such as mean tremor amplitude, dominant frequency, and temporal variability may be analyzed, according to the acquisition protocol;we will observe whether it will be necessary to adopt a significance level of a = 0.05 (two-tailed). Considering the exploratory nature of the study, no formal adjustment for multiple comparisons in the secondary outcomes will be performed, and its results will be interpreted as hypothesis-generating.;It is expected that some statistical power will be found through the analysis of the data that can validate our objective over a period of 2 years; in the case of accelerometry verification, derived variables such as mean tremor amplitude, dominant frequency, and temporal variability may be analyzed, according to the acquisition protocol, we will observe whether it will be necessary to adopt a significance level of a = 0.05 | — |
Countries
BR
Contacts
Public ContactEliane Furtado
Universidade do Estado do Rio de Janeiro
Outcome results
None listed