Comparing Different Montages of tDCS Combined With Dual-task Training on EEG Microstates

Comparing Different Montages of Transcranial Direct Current Stimulation Combined With Dual-task Training on EEG Microstates A Proof-of-concept Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suellen Andrade; Phone Number: +5583999805189; Email: suellenandrade@gmail.com

Study Locations

• Brazil
  • Paraiba
    • João Pessoa, Paraiba, Brazil, 58051-900
      • Recruiting
      • Federal University of Paraíba,Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anodal tDCS + dual-task training; 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. Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.	Device: Transcranial direct current stimulation; 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. Cognitive motor dual-task training (CMDT) is a type of cognitive rehabilitation training at the same time as exercise rehabilitation therapy.; Other Names: tDCS; Dual-task training
Active Comparator: tDCS dualsite + dual-task training; 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. Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.	Device: Transcranial direct current stimulation; 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. Cognitive motor dual-task training (CMDT) is a type of cognitive rehabilitation training at the same time as exercise rehabilitation therapy.; Other Names: tDCS; Dual-task training
Placebo Comparator: tDCS sham + dual-task training; Two electrodes will be used, which will be positioned over the primary motor area (C3/C4) and a reference electrode (6x9 cm) will be used on the deltoid muscle region, however the device will be configured in sham mode. Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.	Device: Transcranial direct current stimulation; 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. Cognitive motor dual-task training (CMDT) is a type of cognitive rehabilitation training at the same time as exercise rehabilitation therapy.; Other Names: tDCS; Dual-task training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microstates EEG	EEG data were processed according to the following steps and parameters: (1) downsampled to 256 Hz; (2) high-pass filter at 2 Hz and low-pass at 20 Hz; (3) visual inspection and artifact removal; (4) correction of eye movement using the independent component analysis; and (5) segmentation into two-second epochs with 10% overlap. The choice for the 2-20 Hz range frequency band. Data were submitted to processing: determination of global field power; clustering using k-means of topographic maps of global field power peaks; determination of the optimal number of topographic maps using a predetermined criterion of the four classic maps (A, B, C, and D); application of the topographic maps to the EEG signal using spatial correlation; and classification of EEG continuous data according to the topographic map with the most correlated sections. We calculated and extracted the global explained variance, coverage, occurrence, and duration from each topography.	The evaluations will be carried out in pre-intervention
Functional connectivity	EEG data were processed according to the following steps and parameters: (1) downsampled to 256 Hz; (2) high-pass filter at 2 Hz and low-pass at 20 Hz; (3) visual inspection and artifact removal; (4) correction of eye movement using the independent component analysis; and (5) segmentation into two-second epochs with 10% overlap. The choice for the 2-20 Hz range frequency band. Data were submitted to processing: determination of global field power; clustering using k-means of topographic maps of global field power peaks; determination of the optimal number of topographic maps using a predetermined criterion of the four classic maps (A, B, C, and D); application of the topographic maps to the EEG signal using spatial correlation; and classification of EEG continuous data according to the topographic map with the most correlated sections. We calculated and extracted the global explained variance, coverage, occurrence, and duration from each topography.	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and Go test	Timed up and Go test	The evaluations will be carried out in pre-intervention
Timed up and Go test	Timed up and Go test	Immediately after the intervention
Executive Functions I	Trial-making Test A and B	The evaluations will be carried out in pre-intervention
Executive Functions I	Trial-making Test A and B	Immediately after the intervention
Executive Functions II	the Clock Drawing Test	The evaluations will be carried out in pre-intervention
Executive Functions II	the Clock Drawing Test	Immediately after the intervention
Executive Functions III	Phonemic Verbal Fluency Test	The evaluations will be carried out in pre-intervention
Executive Functions III	Phonemic Verbal Fluency Test	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; EEG; Transcranial direct current stimulation; Dual-task training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: tDCS+Dual-tasktraining_Stroke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes