Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke
Transcranial direct current stimulation (Anodal tDCS) + dual-task training
+ Transcranial direct current stimulation sham + dual-task training
+ Transcranial direct current stimulation (tDCS dualsite) + dual-task traning
Bronchiolitis Obliterans Syndrome+15
+ Organizing Pneumonia
+ Brain Diseases
Treatment Study
Summary
Study start date: March 10, 2022
Actual date on which the first participant was enrolled.Participants will be divided into 03 groups: G1: anodic tDCS - participants who will receive real current over the primary motor area; G2: dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will be entered into the study through the eligibility criteria and will be randomly allocated, with block exchange at a rate of 1:1:1. In each phase of the study, participants will receive 10 tDCS sessions, for 20 minutes, on alternate days (3 times a week, excluding weekends). The TCT-Research neurostimulator will be used for stimulation. The electrodes will be positioned according to the 10-20 international electroencephalogram classification system. Electrodes wrapped in sponges, moistened with saline solution (0.9% NaCl) will be used. The applied current will be 2mA (5x5 cm active electrodes; 25 cm2; current density of 0.08 mA/cm2). For group 1 (anodic tDCS) the anodic electrode (5x5 cm) will be applied to the primary motor area (C3/C4) ipsilateral to the lesion and the reference electrode (6x9 cm) to the deltoid muscle region. In group 2 (dualsite tDCS) two active electrodes (5x5 cm) will be used, which will be positioned over the primary motor area (C3/C4) and over the dorsolateral prefrontal cortex (F3 or F4) in the ipsilateral hemisphere. For this stimulation modality, two active electrodes (anodic) and a reference electrode (6x9 cm) will be used on the deltoid muscle region. For group 3 (simulated tDCS) the positioning of the electrodes will be the same as for group 1, however the device will be configured in sham mode in which the current will cease 30 seconds after the start of stimulation, in this way the effects of active stimulation will be simulated and the participants will perceive the sensations typically felt, but without the induction of clinical effects (Nitsche \& Paulus, 2000). At the end of each session, participants will be asked to report any unpleasant effects and asked about possible adverse effects. In addition, all participants will be blind to the type of stimulation they will receive.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Single episode of unilateral, ischemic stroke in middle cerebral artery proven by means of magnetic resonance imaging or computed tomography. * Classification of brain injury based on the criteria: Oxfordshire Community Stroke Project (OCSP) or Trial of Org 10172 in Acute Stroke Treatment (TOAST); * Patients in the chronic stage (after six months after the injury) * Individuals over 18 years of age; * Both sexes; * Absence of mental disorders, assessed using the Self Reporting Questionnaire (SRQ-20), with a cut-off point of 7/8 points. * Absence of cognitive deficits, assessed using the Mini Mental State Examination (MMSE\> 24). * Patients with mild to moderate degree of injury severity (NIHHS \<17 points). Exclusion Criteria: * Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor); •- Participants unable to complete the initial assessment due to severe aphasia (Token Test \<17); * habitual use of drugs or alcohol; * Use of drugs that modulate the activity of the Central Nervous System; * Gestation; * Use of metallic / electronic implants and / or cardiac pacemakers;
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Federal University of Paraíba,Department of Psychology
João Pessoa, BrazilOpen Federal University of Paraíba,Department of Psychology in Google Maps