Clinical trial NCT05547126: Comparing Different Montages of tDCS Combined With Dual-task Training on EEG Microstates
Official title: Comparing Different Montages of Transcranial Direct Current Stimulation Combined With Dual-task Training on EEG Microstates A Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Transcranial direct current stimulation
Stroke
Dual-task training
EEG
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigates whether electroencephalographic (EEG) measures of functional connectivity of the target network are associated with the response to different sets of transcranial direct current stimulation combined with dual-task training in post-stroke patients.

Detailed description: The present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dual-site anodic tDCS (M1 + DLPFC) and simulated tDCS on functional connectivity, as assessed by EEG, in patients after staged stroke. chronic. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial. Participants will be submitted to three sessions, each session consisting of a different condition, namely: anodic tDCS - participants who will receive real current over the primary motor area; Dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and simulated tDCS - participants who will receive simulated stimulation. Participants will receive 3 tDCS sessions, lasting 20 minutes, associated with a physical therapy protocol based on dual motor and cognitive tasks, on alternate days (3 times a week). On each intervention day, pre and post-intervention assessments will be carried out, the evaluated outcomes will be: functional connectivity (EEG), functional mobility (Timed Up and Go) and executive functions (Trail-making Test A and B, the Clock Drawing Test and Phonemic Verbal Fluency Test). Statistical performance will be performed using SPSS software (Version 20.0) and MATLAB 9.20 with a significance level of p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Post-stroke participants for more than 6 months
* Individuals over 18 years of age;
* Both sexes;
* 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);
* 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;
* Participants unable to communicate verbally;

Primary outcomes:
measure: Microstates EEG
timeFrame: The evaluations will be carried out in pre-intervention
measure: Functional connectivity
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Timed up and Go test
timeFrame: The evaluations will be carried out in pre-intervention
measure: Timed up and Go test
timeFrame: Immediately after the intervention
measure: Executive Functions I
timeFrame: The evaluations will be carried out in pre-intervention
measure: Executive Functions I
timeFrame: Immediately after the intervention
measure: Executive Functions II
timeFrame: The evaluations will be carried out in pre-intervention
measure: Executive Functions II
timeFrame: Immediately after the intervention
measure: Executive Functions III
timeFrame: The evaluations will be carried out in pre-intervention
measure: Executive Functions III
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraiba
Study officials:
affiliation: Federal University of Paraíba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References: