Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial

NCT04850963 | Unknown

• 1 other identifier: AVCtDCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Chronic

Keywords

Stroke; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer assessment (FMA) pre-intervention (T0)

  Fugl-Meyer assessment (FMA) for lower limbs pre-intervention (T0)

  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)

  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 evaluations will be carried out in pre-intervention (T0)

• Functional connectivity (EEG) after the stimulation protocol (T1)

  The T1 assessment will be performed up to one week after the stimulation protocol is completed.

• EQ-5D (T0)

  The evaluations will be carried out in pre-intervention (T0).

• EQ-5D (T1)

  The T1 assessment will be performed up to one week after the stimulation protocol is completed.

• Modified Rankin Scale pre-intervention (T0)

  The evaluations will be carried out in pre-intervention (T0).

Study Arms (3)

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.

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.

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.

Device: Transcranial direct current stimulation (Anodal tDCS) + dual-task training; Device: Transcranial direct current stimulation (tDCS dualsite) + dual-task traning

Interventions

Transcranial direct current stimulation (Anodal tDCS) + dual-task training DEVICE

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.

Also known as: anodal tDCS

Group 2 - tDCS dualsite; Group 3 - tDCS sham

Transcranial direct current stimulation (tDCS dualsite) + dual-task traning DEVICE

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.

Also known as: tDCS dualsite

Group 1 - anodal tDCS; Group 3 - tDCS sham

Transcranial direct current stimulation sham + dual-task training DEVICE

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.

Also known as: tDCS sham

Group 1 - anodal tDCS; Group 2 - tDCS dualsite

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

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; Bronchiolitis Obliterans Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 20, 2021
• Study Start: March 10, 2022
• Primary Completion: December 24, 2022
• Study Completion: December 24, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)