Comparing Different Montages of tDCS Combined With Dual-task Training on EEG Assessed Functional Connectivity
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 - anodal tDCS + dual-task training The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. For group 1 (anodic tDCS) 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 to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The 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:
|
| Active Comparator: Group 2 - tDCS dualsite + dual-task training The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. In group 2 (dualsite tDCS) 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 to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The 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:
|
| No Intervention: Group 3 - tDCS sham + dual-task training The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. For group 3 (simulated tDCS) the positioning of the electrodes will be the same as for group 1, however the device will be configured in sham mode in which the current will cease 30 seconds after the start of stimulation. Participants will receive 1 tDCS sessions, for 20 minutes. Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session |
Outcome Measures
Primary Outcome Measures
- Functional connectivity [The evaluations will be carried out in pre-intervention]
Functional connectivity assessed by EEG. EEG data from 32 channels were collected using the EPOC FLEX 32-Channel Wireless, with Ag-AgCl electrodes channels. EPOC Flex features built-in data pre-processing, including a 0.2 Hz high-pass filter, a 45 Hz low-pass filter, 1024 Hz scanning, 5th-order filtering (digital 5th-order sync filter) and sampling rate of 128 Hz. The spectrum of EEG signals will be divided into six frequency bands: delta (1-4Hz), theta (4-8 Hz), slow alpha (8-10 Hz), fast alpha (10-13.5 Hz), beta (13.5-30Hz) and gamma (>30Hz). The debiased weighted phase lag index (dwPLI) was computed to estimate functional connectivity between electrodes.
- Functional connectivity [Immediately after the intervention]
Functional connectivity assessed by EEG. EEG data from 32 channels were collected using the EPOC FLEX 32-Channel Wireless, with Ag-AgCl electrodes channels. EPOC Flex features built-in data pre-processing, including a 0.2 Hz high-pass filter, a 45 Hz low-pass filter, 1024 Hz scanning, 5th-order filtering (digital 5th-order sync filter) and sampling rate of 128 Hz. The spectrum of EEG signals will be divided into six frequency bands: delta (1-4Hz), theta (4-8 Hz), slow alpha (8-10 Hz), fast alpha (10-13.5 Hz), beta (13.5-30Hz) and gamma (>30Hz). The debiased weighted phase lag index (dwPLI) was computed to estimate functional connectivity between electrodes.
Secondary Outcome Measures
- Timed up and Go test [The evaluations will be carried out in pre-intervention]
Timed up and Go test (TUG)
- Timed up and Go test [Immediately after the intervention]
Timed up and Go test (TUG)
- Executive Functions I [The evaluations will be carried out in pre-intervention]
Trial-making Test A and B (TMT)
- Executive Functions I [Immediately after the intervention]
Trial-making Test A and B (TMT)
- Executive Functions II [The evaluations will be carried out in pre-intervention]
the Clock Drawing Test (CDT)
- Executive Functions II [Immediately after the intervention]
the Clock Drawing Test (CDT)
- Executive Functions III [The evaluations will be carried out in pre-intervention]
Phonemic Verbal Fluency Test F-A-S
- Executive Functions III [Immediately after the intervention]
Phonemic Verbal Fluency Test F-A-S
Eligibility Criteria
Criteria
Inclusion Criteria:
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Post-stroke participants for more than 6 months
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Individuals over 18 years of age;
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Both sexes;
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Patients with mild to moderate degree of injury severity (NIHHS <17 points)
Exclusion Criteria:
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Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor);
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Habitual use of drugs or alcohol;
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Use of drugs that modulate the activity of the Central Nervous System;
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Gestation;
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Use of metallic / electronic implants and / or cardiac pacemakers;
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Participants unable to communicate verbally;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal University of Paraíba,Department of Psychology | João Pessoa | Paraiba | Brazil | 58051-900 |
Sponsors and Collaborators
- Federal University of Paraíba
Investigators
- Principal Investigator: Suellen Andrade, Federal University of Paraíba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- tDCS+Dual-tasktraining_Stroke