Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Participants will be divided into 03 groups: G1: anodic tDCS - participants who will receive real current over the primary motor area; G2: dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will be entered into the study through the eligibility criteria and will be randomly allocated, with block exchange at a rate of 1:1:1.
In each phase of the study, participants will receive 10 tDCS sessions, for 20 minutes, on alternate days (3 times a week, excluding weekends). The TCT-Research neurostimulator will be used for stimulation. The electrodes will be positioned according to the 10-20 international electroencephalogram classification system. Electrodes wrapped in sponges, moistened with saline solution (0.9% NaCl) will be used. The applied current will be 2mA (5x5 cm active electrodes; 25 cm2; current density of 0.08 mA/cm2).
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. 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.
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, in this way the effects of active stimulation will be simulated and the participants will perceive the sensations typically felt, but without the induction of clinical effects (Nitsche & Paulus, 2000). At the end of each session, participants will be asked to report any unpleasant effects and asked about possible adverse effects. In addition, all participants will be blind to the type of stimulation they will receive.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Suellen Andrade
- Telefoonnummer: +5583999805189
- E-mail: suellenandrade@gmail.com
Studie Locaties
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Paraíba
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João Pessoa, Paraíba, Brazilië, 58051-900
- Werving
- Federal University of Paraíba,Department of Psychology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Single episode of unilateral, ischemic stroke in middle cerebral artery proven by means of magnetic resonance imaging or computed tomography.
- Classification of brain injury based on the criteria: Oxfordshire Community Stroke Project (OCSP) or Trial of Org 10172 in Acute Stroke Treatment (TOAST);
- Patients in the chronic stage (after six months after the injury)
- Individuals over 18 years of age;
- Both sexes;
- Absence of mental disorders, assessed using the Self Reporting Questionnaire (SRQ-20), with a cut-off point of 7/8 points.
- Absence of cognitive deficits, assessed using the Mini Mental State Examination (MMSE> 24).
- 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);
•- Participants unable to complete the initial assessment due to severe aphasia (Token Test <17);
- 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;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group 1 - anodal tDCS
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). 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. |
tDCS dualsite 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
tDCS sham 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
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Actieve vergelijker: Group 2 - tDCS dualsite
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). 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. |
tDCS sham 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
anodal tDCS 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
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Placebo-vergelijker: Group 3 - tDCS sham
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). 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. 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. |
tDCS dualsite 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
anodal tDCS 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fugl-Meyer assessment (FMA) pre-intervention (T0)
Tijdsspanne: The evaluations will be carried out in pre-intervention (T0)
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Fugl-Meyer assessment (FMA) for lower limbs pre-intervention (T0)
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The evaluations will be carried out in pre-intervention (T0)
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Fugl-Meyer assessment (FMA) after the stimulation protocol (T1)
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Fugl-Meyer assessment (FMA) for lower limbs after the stimulation protocol (T1)
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Functional connectivity (EEG) pre-intervention (T0)
Tijdsspanne: The evaluations will be carried out in pre-intervention (T0)
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The functional connectivity of the target network will be assessed, through the acquisition of the EEG
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The evaluations will be carried out in pre-intervention (T0)
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Functional connectivity (EEG) after the stimulation protocol (T1)
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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The functional connectivity of the target network will be assessed, through the acquisition of the EEG
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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EQ-5D (T0)
Tijdsspanne: The evaluations will be carried out in pre-intervention (T0).
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Quality of life.
Presenting a final score from 0 to 100, where 0 corresponds to the worst general state of health and 100 the best state of health.
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The evaluations will be carried out in pre-intervention (T0).
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EQ-5D (T1)
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Quality of life.Presenting a final score from 0 to 100, where 0 corresponds to the worst general state of health and 100 the best state of health.
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Modified Rankin Scale pre-intervention (T0)
Tijdsspanne: The evaluations will be carried out in pre-intervention (T0).
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Functional disability. The score on the Rankin scale ranges from 0 to 6, in order to assess the patient's neurological condition, in which the higher the value, the worse the condition. 0 - No symptoms
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The evaluations will be carried out in pre-intervention (T0).
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Modified Rankin Scale after the stimulation protocol (T1)
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Functional disability. The score on the Rankin scale ranges from 0 to 6, in order to assess the patient's neurological condition, in which the higher the value, the worse the condition. 0 - No symptoms
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Balance
Tijdsspanne: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Biodex Balance System (BBS)
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The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Balance
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Biodex Balance System (BBS)
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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MoCA
Tijdsspanne: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Cognitive function
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The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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MoCA
Tijdsspanne: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Cognitive function
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
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Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AVCtDCS
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