CEEG Changes After Tdcs and Dual-task Training

NCT ID: NCT05492435

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-01

Brief Summary

Stroke has been considered one of the main causes of long-term disability in the adult population. Technological advances in the neurological area have been observed in the last decades, which accentuates the interest in promoting non-invasive stimulation techniques, capable of modulating brain polarity, where among these techniques is the transcranial direct current stimulation - tDCS. Previous studies analyzed by systematic reviews suggest that the effects of tDCS may vary between individuals, where some stroke patients may not receive any additional benefit from the therapy. Thus, it is necessary to use a biomarker that can choose those that will possibly benefit from the electric current. Therefore, the aim of this study is to identify the dynamics of EEG microstates after tDCS and dual-task training in subjects after chronic stroke, as well as to assess how microstate parameters in stroke patients are altered by tDCS and dual-task training. at three different moments (Stimulation in M1 + dual-task training; Stimulation in M1 and DLPF + dual-task training; Sham stimulation) and to observe whether the microstates encode information that reflects the motor and/or cognitive capacity of these patients.

Detailed Description

Cerebrovascular Accident (CVA) has been considered one of the main causes of long-term disability in the adult population. Stroke usually causes deficits such as asymmetrical muscle weakness between limbs, impaired proprioceptive ability, sensory loss, vision problems, and spasticity. In post-stroke patients, it is believed that the interhemispheric balance may be altered as a result of brain injury, the theory of interhemispheric competition is widely used as a theoretical basis for the application of non-invasive neuromodulatory techniques. Technological advances in the neurological field have been seen in recent decades, which accentuates the interest in promoting non-invasive stimulation techniques, capable of modulating brain polarity, where among these techniques is transcranial direct current stimulation - tDCS. Previous studies analyzed by systematic reviews suggest that the effects of tDCS may vary between subjects, where some stroke patients may not receive any additional benefit from the therapy. Thus, it is necessary to use a biomarker that can choose those who will possibly benefit from the electric current. Therefore, the aim of this study is to identify the dynamics of EEG microstates after tDCS and dual-task training in subjects after chronic stroke, as well as to assess how microstate parameters in stroke patients are altered by tDCS and dual-task training at three different times (Stimulation in M1 + dual-task training; Stimulation in M1 and DLPF + dual-task training; Sham stimulation) and observe whether the microstates encode information that reflects the motor and/or cognitive capacity of these patients. For this, a clinical trial, sham-controlled, double-blind and randomized, of crossover type, involving patients with stroke in chronic stage will be carried out. Participants will be submitted to three sessions, each session consisting of a different condition, namely: first condition (anodic tDCS) participants will receive real current over the primary motor area (M1); second condition (dualsite tDCS) participants will receive real current over M1 and dorsolateral prefrontal area (DLPFC) and third condition (sham tDCS) participants will receive simulated stimulation. A 3-minute resting EEG will be collected from each participant, and they will be instructed not to actively engage in any cognitive or mental activity. In all stimulation sessions, evaluations will be carried out, the evaluated outcomes will be: change in EEG microstates, cognitive function and motor function. Statistical analyzes will be performed using SPSS software (Statistical Package for Social Sciences - SPSS Inc, Chicago IL, USA for Windows, Version 20.0) and MATLAB (9.2.0 (MathWorks, Inc., Natick, MA) with a defined level of significance at p<0.05.

Conditions

Stroke; Electroencephalogram

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

m1 stimulation + dual task training

participants will receive real current over the primary motor area (M1)

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

tDCS can regulate cortical excitability by influencing membrane polarity, where anodic current increases excitability and cathodic current reduces excitability. Therefore, in post-stroke patients when the anode is applied to the cerebral hemisphere ipsilesional to the lesion or the cathode to the contralesional hemisphere, the balance between the interhemispheres tends to be restored.

stimulation in M1 and DLPF + dual task training

participants will receive real current over the M1 and over the dorsolateral prefrontal area (DLPFC)

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

tDCS can regulate cortical excitability by influencing membrane polarity, where anodic current increases excitability and cathodic current reduces excitability. Therefore, in post-stroke patients when the anode is applied to the cerebral hemisphere ipsilesional to the lesion or the cathode to the contralesional hemisphere, the balance between the interhemispheres tends to be restored.

sham stimulation + dual task training

Participants will receive simulated stimulation

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

tDCS can regulate cortical excitability by influencing membrane polarity, where anodic current increases excitability and cathodic current reduces excitability. Therefore, in post-stroke patients when the anode is applied to the cerebral hemisphere ipsilesional to the lesion or the cathode to the contralesional hemisphere, the balance between the interhemispheres tends to be restored.

Interventions

transcranial direct current stimulation

tDCS can regulate cortical excitability by influencing membrane polarity, where anodic current increases excitability and cathodic current reduces excitability. Therefore, in post-stroke patients when the anode is applied to the cerebral hemisphere ipsilesional to the lesion or the cathode to the contralesional hemisphere, the balance between the interhemispheres tends to be restored.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals diagnosed with stroke for more than 6 months;

Proven by means of magnetic resonance imaging or computed tomography;

Individuals aged 18 and over;

Both sexes;

Patients with mild to moderate degree of injury severity (NIHHS < 17 points)

Exclusion Criteria

• Individuals who are unable to communicate verbally;

Use of drugs that modulate the activity of the Central Nervous System;

Carriers of implanted metallic or electronic devices; cardiac pacemaker;

Habitual use of drugs or alcohol;

Report of history of epilepsy; gestation; people with traumatic brain injury or tumors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Suellen Andrade

Dra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suellen Andrade, Dra

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

Locations

Aging and Neuroscience Studies Laboratory

João Pessoa, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

LETICIA MARIA

Role: CONTACT

leticiamaria.fisio@gmail.com

81 993684588

Facility Contacts

Suellen Andrade

Role: primary

Other Identifiers

microstates_stroke

Identifier Type: -

Identifier Source: org_study_id