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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Transcranial direct current stimulation, Stroke, Dual-task training, EEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Federal University of Paraíba,Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Anodal tDCS + dual-task training

tDCS dualsite + dual-task training

tDCS sham + dual-task training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Timed up and Go test
Timed up and Go test
Timed up and Go test
Timed up and Go test
Executive Functions I
Trial-making Test A and B
Executive Functions I
Trial-making Test A and B
Executive Functions II
the Clock Drawing Test
Executive Functions II
the Clock Drawing Test
Executive Functions III
Phonemic Verbal Fluency Test
Executive Functions III
Phonemic Verbal Fluency Test

Full Information

First Posted
August 18, 2022
Last Updated
April 21, 2023
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT05547126
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Transcranial direct current stimulation, Stroke, Dual-task training, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS + dual-task training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tDCS dualsite + dual-task training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tDCS sham + dual-task training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS, Dual-task training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microstates EEG
Description
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.
Time Frame
The evaluations will be carried out in pre-intervention
Title
Functional connectivity
Description
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.
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Timed up and Go test
Description
Timed up and Go test
Time Frame
The evaluations will be carried out in pre-intervention
Title
Timed up and Go test
Description
Timed up and Go test
Time Frame
Immediately after the intervention
Title
Executive Functions I
Description
Trial-making Test A and B
Time Frame
The evaluations will be carried out in pre-intervention
Title
Executive Functions I
Description
Trial-making Test A and B
Time Frame
Immediately after the intervention
Title
Executive Functions II
Description
the Clock Drawing Test
Time Frame
The evaluations will be carried out in pre-intervention
Title
Executive Functions II
Description
the Clock Drawing Test
Time Frame
Immediately after the intervention
Title
Executive Functions III
Description
Phonemic Verbal Fluency Test
Time Frame
The evaluations will be carried out in pre-intervention
Title
Executive Functions III
Description
Phonemic Verbal Fluency Test
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Andrade
Phone
+5583999805189
Email
suellenandrade@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Organizational Affiliation
Federal University of Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa
State/Province
Paraiba
ZIP/Postal Code
58051-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, Phd
Phone
986046032
Ext
5583
Email
suellenadrade@gmail.com

12. IPD Sharing Statement

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

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