Parkinson&apos
Conditions
Interventions
This is a randomized, triple-blind, sham-controlled, longitudinal clinical trial. It will consist of four study groups: Group I, composed of people with PD who will receive active neuromodulation for
Group II, composed of people with PD who will receive active neuromodulation and cognitive training for one week
Group III, composed of people with PD who will receive sham neuromodulation for one week
and Group IV, composed of people with PD who will receive sham neuromodulation and cognitive training for one week. Assessments will occur at four distinct time points: (1) pre-intervention
(2) post-intervention
(3) one month after intervention
and (4) six months after intervention to analyze lasting effects. Multivariate analyses will be performed to assess whether the study groups will show significant differences in the variables evaluate
b) the initials were placed in envelopes
c) the study coordinator generated an allocation sequence from the distribution of the envelopes
d) participants and administrators were not informed about the type of intervention
and e) independent researchers conducted the statistical analyses and were unaware of the condition being analyzed (Higgins et al., 2019
Sponsors
Centro de Ciências Humanas, Letras e Artes da Universidade Federal da Paraíba
Centro de Ciências Humanas, Letras e Artes da Universidade Federal da Paraíba
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The study included people diagnosed with Parkinson disease of both sexes aged up to 60 years (Bagattini et al., 2023). They have a disease staging score between 1.0 and 2.5, which is considered compatible with the development of responses during application of the neurocognitive test battery (Hoehn & Yahr, 1968). They have not been diagnosed with dementia. They have normal or corrected visual acuity, as measured using Rasquin E optotypes No diagnosis of dementia. Normal or corrected visual acuity 20/20 measured using Rasquin “E” optotypes.
Exclusion criteria
Exclusion criteria: The presence of metal implants and/or pacemakers. History of seizures. Participants with comorbidities such as diabetes mellitus, high blood pressure, schizophrenia and bipolar disorder. Use of illicit psychoactive substances and/or benzodiazepines within one week of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the cognitive performance of people with Parkinson's disease (PD) after intervention with active transcranial direct current stimulation (tDCS), compared to the sham group. Verified through the application of standardized neuropsychological tests. The outcome will be considered to have occurred if the active tDCS group shows statistically significant improvement in cognitive task scores compared to the sham group, based on mixed variance analyses with p < 0.05 and effect sizes greater than 0.5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of the combination of Transcranial Direct Current Stimulation (tDCS) and cognitive training on cognitive performance in people with Parkinson's disease (PD). Using the same set of neuropsychological tests applied to groups with active and sham tDCS, with and without cognitive training. The outcome will be considered to have occurred when statistically significant differences are observed between the combined groups (active + training, active without training, sham + training, sham without training), with p < 0.05 and relevant effect size (partial ?² > 0.06);To evaluate performance in eye tracking tasks in participants with Parkinson's disease (PD) after intervention with active transcranial direct current stimulation (tDCS), compared to the sham group. Verified through visual search tasks in a standardized protocol with eye tracking data collection. The outcome will be considered to have occurred if the active tDCS group shows improvement in reaction time, number of fixations, and average fixation duration parameters, with statistically significant differences (p < 0.05) compared to the sham group;Investigate the cortical activity of people with Parkinson's disease (PD) after intervention with active transcranial direct current stimulation (tDCS), compared to the activity of the sham group. Using electroencephalography, with recording at rest and during cognitive tasks, followed by spectral and functional connectivity analysis. The outcome will be considered to have occurred if significant differences in frequency bands (e.g., increased activity in the theta or alpha band) are identified between the groups, based on appropriate statistical analysis (p < 0.05 and relevant microvolt amplitude);Analyze serum levels of pro-inflammatory biomarkers in people with Parkinson's disease (PD) before and after intervention with active transcranial direct current stimulation (tDCS). Using immunoassay methods to quantify cyt | — |
Countries
Brazil
Contacts
Public ContactJandirlly Pequeno
Universidade Federal da Paraíba
Outcome results
None listed