Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Stroke Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

Participants will be divided into 02 groups: G1: Experimental - participants who will receive real current; G2: Sham - participants who will receive simulated stimulation. Participants will be included in the study using the eligibility criteria and will be randomly allocated, with exchange in block...

Participants will be divided into 02 groups: G1: Experimental - participants who will receive real current; G2: Sham - participants who will receive simulated stimulation. Participants will be included in the study using the eligibility criteria and will be randomly allocated, with exchange in blocks at the rate of 1: 1. Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20, in which the anode will be applied in the primary motor area (C3 / C4) ipsilateral to the lesion and the cathode in the contralateral supra-orbital region. The current intensity will be defined based on computational modeling, using the patient's magnetic resonance as a basis, in order to estimate and individualize the dosage to be administered. The SimNIBS software will be used for computational modeling, it is a free and open source package for the simulation of the electric field induced individually by tDCS in the brain. The modeling will be performed from T1-weighted magnetic resonance images in order to build a high resolution head model for each individual. These images are segmented into the main tissues of the head (white and gray substance, cerebrospinal fluid, skull and scalp). From the segmentations, a volume conductor model is created and used to perform the electric field simulations. The estimated distribution of the cerebral electric field is obtained by placing simulated electrodes on the head model and defining the intensity of the electric current according to the stimulation protocol.

Tracking Information

NCT #
NCT04850963
Collaborators
Not Provided
Investigators
Principal Investigator: Suellen Andrade Federal University of Paraíba