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

NCT05547126 | Unknown FDA Device

• 1 other identifier: tDCS+Dual-tasktraining_Stroke
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Transcranial direct current stimulation; Stroke; Dual-task training; EEG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Timed up and Go test

  The evaluations will be carried out in pre-intervention

• Timed up and Go test

  Immediately after the intervention

• Executive Functions I

  The evaluations will be carried out in pre-intervention

• Executive Functions I

  Immediately after the intervention

• Executive Functions II

  The evaluations will be carried out in pre-intervention

Study Arms (3)

Anodal tDCS + dual-task training

ACTIVE COMPARATOR

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

tDCS dualsite + dual-task training

ACTIVE COMPARATOR

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

tDCS sham + dual-task training

PLACEBO COMPARATOR

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

Interventions

Transcranial direct current stimulation DEVICE

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.

Also known as: tDCS, Dual-task training

Anodal tDCS + dual-task training; tDCS dualsite + dual-task training; tDCS sham + dual-task training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, 58051-900, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suellen Andrade

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen Andrade

CONTACT

+5583999805189; suellenandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Federal University of Paraíba

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 21, 2022
• Study Start: July 4, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

BR (1)