Stroke, ChronicNCT04850963
Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial
A study testing Transcranial direct current stimulation (Anodal tDCS) + dual-task training and Transcranial direct current stimulation (tDCS dualsite) + dual-task traning in people with Stroke, Chronic, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
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. However, evidence of the effects of tDCS on lower limb motor recovery after stroke remains scarce and inconclusive. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Chronic
- What is being tested?
- Transcranial direct current stimulation (Anodal tDCS) + dual-task training and Transcranial direct current stimulation (tDCS dualsite) + dual-task traning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2022to 24 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
Suellen Andrade, 986046032 ext. 55 83, suellenandrade@gmail.com
Suellen Andrade
About this study
Official title: Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke
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. However, evidence of the effects of tDCS on lower limb motor recovery after stroke remains scarce and inconclusive. Furthermore, little is known about the effects of dualsite tDCS in chronic patients. Therefore, the present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dualsite anodic tDCS (M1 + DLPFC) and simulated tDCS on lower limb motor function in patients after ischemic stroke in a chronic stage. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial with subjects after stroke. After recruitment and initial screening, participants will be randomized into three 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 dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will receive 10 tDCS sessions, for 20 minutes, associated with a physical therapy protocol based on a dual motor and cognitive task, on alternate days (3 times a week). In each phase of the study, pre- and post-intervention evaluations will be carried out, the evaluated outcomes will be: motor function (Fugl-Meyer Scale), functional connectivity (EEG), quality of life (EQ-5D), level of functional disability ( Rankin Scale), static balance (Biodex Balance System) and cognitive function (MoCA). Statistical analyzes will be performed using SPSS software (Version 20.0) and MATLAB 9.2.0 with a significance level of p <0.05.
Read the detailed description
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.
- Conditions
- Stroke, Chronic
- Being tested
- Transcranial direct current stimulation (Anodal tDCS) + dual-task training, Transcranial direct current stimulation (tDCS dualsite) + dual-task traning, Transcranial direct current stimulation sham + dual-task training
- Keywords
- Stroke, Transcranial direct current stimulation
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (Anodal tDCS) + dual-task trainingDevice
Also called anodal tDCS
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.
Transcranial direct current stimulation (tDCS dualsite) + dual-task traningDevice
Also called tDCS dualsite
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.
Transcranial direct current stimulation sham + dual-task trainingDevice
Also called tDCS sham
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - anodal tDCS | Active comparator | 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. Receives: Device: Transcranial direct current stimulation (tDCS dualsite) + dual-task traning; Device: Transcranial direct current stimulation sham + dual-task training |
| Group 2 - tDCS dualsite | Active comparator | 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. Receives: Device: Transcranial direct current stimulation (Anodal tDCS) + dual-task training; Device: Transcranial direct current stimulation sham + dual-task training |
| Group 3 - tDCS sham | Placebo comparator | 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. Receives: Device: Transcranial direct current stimulation (Anodal tDCS) + dual-task training; Device: Transcranial direct current stimulation (tDCS dualsite) + dual-task traning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment (FMA) pre-intervention (T0)
Fugl-Meyer assessment (FMA) for lower limbs pre-intervention (T0)
Measured: The evaluations will be carried out in pre-intervention (T0)
Fugl-Meyer assessment (FMA) after the stimulation protocol (T1)
Fugl-Meyer assessment (FMA) for lower limbs after the stimulation protocol (T1)
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Secondary outcomes (10)
Functional connectivity (EEG) pre-intervention (T0)
The functional connectivity of the target network will be assessed, through the acquisition of the EEG
Measured: The evaluations will be carried out in pre-intervention (T0)
Functional connectivity (EEG) after the stimulation protocol (T1)
The functional connectivity of the target network will be assessed, through the acquisition of the EEG
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
EQ-5D (T0)
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.
Measured: The evaluations will be carried out in pre-intervention (T0).
EQ-5D (T1)
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.
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Modified Rankin Scale pre-intervention (T0)
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
- - No significant disabilities
- - Mild disability
- - Moderate disability
- - Moderate-severe disability
- - Severe disability
- - Death
Measured: The evaluations will be carried out in pre-intervention (T0).
Modified Rankin Scale after the stimulation protocol (T1)
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
- - No significant disabilities
- - Mild disability
- - Moderate disability
- - Moderate-severe disability
- - Severe disability
- - Death
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Balance
Biodex Balance System (BBS)
Measured: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
Balance
Biodex Balance System (BBS)
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
MoCA
Cognitive function
Measured: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
MoCA
Cognitive function
Measured: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start10 Mar 2022
- Primary completion24 Dec 2022 (estimated)
- Study completion24 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850963
- Sponsor's protocol ID
- AVCtDCS
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke
- ClinicalTrials.gov ID
- NCT04850963
- Acronym / sponsor ID
- AVCtDCS
- Conditions
- Stroke, Chronic
- Keywords
- Stroke, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 24 Dec 2022 (estimated)
- Study completion
- 24 Dec 2022 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, evidence of the effects of tDCS on lower limb motor recovery after stroke remains scarce and inconclusive. Furthermore, little is known about the effects of dualsite tDCS in chronic patients. Therefore, the present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dualsite anodic tDCS (M1 + DLPFC) and simulated tDCS on lower limb motor function in patients after ischemic stroke in a chronic stage. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial with subjects after stroke. After recruitment and initial screening, participants will be randomized into three 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 dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will receive 10 tDCS sessions, for 20 minutes, associated with a physical therapy protocol based on a dual motor and cognitive task, on alternate days (3 times a week). In each phase of the study, pre- and post-intervention evaluations will be carried out, the evaluated outcomes will be: motor function (Fugl-Meyer Scale), functional connectivity (EEG), quality of life (EQ-5D), level of functional disability ( Rankin Scale), static balance (Biodex Balance System) and cognitive function (MoCA). Statistical analyzes will be performed using SPSS software (Version 20.0) and MATLAB 9.2.0 with a significance level of p <0.05.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - anodal tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS dualsite) + dual-task traning, Device: Transcranial direct current stimulation sham + dual-task trainingParticipants 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. |
| Group 2 - tDCS dualsite | Active comparator | Device: Transcranial direct current stimulation (Anodal tDCS) + dual-task training, Device: Transcranial direct current stimulation sham + dual-task trainingParticipants 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. |
| Group 3 - tDCS sham | Placebo comparator | Device: Transcranial direct current stimulation (Anodal tDCS) + dual-task training, Device: Transcranial direct current stimulation (tDCS dualsite) + dual-task traningParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (Anodal tDCS) + dual-task trainingAlso: anodal tDCSanodal 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. | Device | Group 2 - tDCS dualsite, Group 3 - tDCS sham |
| Transcranial direct current stimulation (tDCS dualsite) + dual-task traningAlso: tDCS dualsitetDCS 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. | Device | Group 1 - anodal tDCS, Group 3 - tDCS sham |
| Transcranial direct current stimulation sham + dual-task trainingAlso: tDCS shamtDCS 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. | Device | Group 1 - anodal tDCS, Group 2 - tDCS dualsite |
Primary outcome
Fugl-Meyer assessment (FMA) pre-intervention (T0)
Time frame: The evaluations will be carried out in pre-intervention (T0)
Fugl-Meyer assessment (FMA) for lower limbs pre-intervention (T0)
Fugl-Meyer assessment (FMA) after the stimulation protocol (T1)
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Fugl-Meyer assessment (FMA) for lower limbs after the stimulation protocol (T1)
10 secondary outcomes
Functional connectivity (EEG) pre-intervention (T0)
Time frame: The evaluations will be carried out in pre-intervention (T0)
Functional connectivity (EEG) after the stimulation protocol (T1)
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
EQ-5D (T0)
Time frame: The evaluations will be carried out in pre-intervention (T0).
EQ-5D (T1)
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Modified Rankin Scale pre-intervention (T0)
Time frame: The evaluations will be carried out in pre-intervention (T0).
Modified Rankin Scale after the stimulation protocol (T1)
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Balance
Time frame: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
Balance
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
MoCA
Time frame: The T0 assessment will be performed up to one week after the stimulation protocol is completed.
MoCA
Time frame: The T1 assessment will be performed up to one week after the stimulation protocol is completed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen Andrade principal investigator
Federal University of Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (Anodal tDCS) + dual-task training and Transcranial direct current stimulation (tDCS dualsite) + dual-task traning in people with Stroke, Chronic, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade (+5583999805189, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer assessment (FMA) pre-intervention (T0) (time frame: The evaluations will be carried out in pre-intervention (T0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.