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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547126
• Other study ID #: tDCS+Dual-tasktraining_Stroke
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Federal University of Paraíba
• Contact: Suellen Andrade
• Phone: +5583999805189
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba,Department of Psychology	João Pessoa	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

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