Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial

Summary

It is currently known that Transcranial Direct Current Stimulation (tDCS) can modulate cortical activity, being considered an important resource in the treatment of sequelae resulting from stroke. However, evidence of the effects of tDCS on lower limb motor recovery after stroke remains scarce and inconclusive. Furthermore, little is known about the effects of dualsite tDCS in chronic patients. Therefore, the present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dualsite anodic tDCS (M1 + DLPFC) and simulated tDCS on lower limb motor function in patients after ischemic stroke in a chronic stage. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial with subjects after stroke. After recruitment and initial screening, participants will be randomized into three 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 dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will receive 10 tDCS sessions, for 20 minutes, associated with a physical therapy protocol based on a dual motor and cognitive task, on alternate days (3 times a week). In each phase of the study, pre- and post-intervention evaluations will be carried out, the evaluated outcomes will be: motor function (Fugl-Meyer Scale), functional connectivity (EEG), quality of life (EQ-5D), level of functional disability ( Rankin Scale), static balance (Biodex Balance System) and cognitive function (MoCA). Statistical analyzes will be performed using SPSS software (Version 20.0) and MATLAB 9.2.0 with a significance level of p \<0.05.

Conditions

• Stroke, Chronic

Interventions

DEVICE

Transcranial direct current stimulation (Anodal tDCS) + dual-task training

anodal tDCS 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.

DEVICE

Transcranial direct current stimulation (tDCS dualsite) + dual-task traning

tDCS dualsite 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.

DEVICE

Transcranial direct current stimulation sham + dual-task training

tDCS sham 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.

Sponsors & Collaborators

• Federal University of Paraíba

  lead OTHER

Principal Investigators

• Suellen Andrade · Federal University of Paraíba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2022-12-24

Completion

2022-12-24

Countries

• Brazil

Study Locations