CEEG Changes After Tdcs and Dual-task Training

NCT05492435 | Unknown

• 1 other identifier: microstates_stroke
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• Changes in EEG microstates in each stimulation condition

  Microstate analysis was performed using the EEGLAB microstate plugin developed by Thomas Koenig (Koenig, 2021). First, at the individual level, we compute global field power (GFP) across all channels and microstate segmentation using the modified k-means clustering algorithm method to isolate map topographies. Polarity was ignored during microstate analysis. After obtaining the microstate segmentation of each participant, we calculated an average of the microstate segmentation of each group as models. The successive original individual EEG series were then divided into four classic microstate maps (they are labeled as four classes A, B, C and D, which are left-right direction (type A), left-right direction (type B), anteroposterior direction (type C) and frontocentral maximum (type D)).

  immediately after the sessions

Secondary Outcomes (4)

• Cognitive function - trail test (TMT) A and B

  immediately after the sessions

• Cognitive function - clock drawing test

  immediately after the sessions

• Cognitive function - verbal fluency test (VF).

  immediately after the sessions

• motor function

  immediately after the sessions

Study Arms (3)

m1 stimulation + dual task training

EXPERIMENTAL

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

Device: transcranial direct current stimulation

stimulation in M1 and DLPF + dual task training

EXPERIMENTAL

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

Device: transcranial direct current stimulation

sham stimulation + dual task training

SHAM COMPARATOR

Participants will receive simulated stimulation

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation 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.

m1 stimulation + dual task training; sham stimulation + dual task training; stimulation in M1 and DLPF + dual task training

Eligibility Criteria

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

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Aging and Neuroscience Studies Laboratory

João Pessoa, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suellen Andrade, Dra

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LETICIA MARIA

CONTACT

81 993684588; leticiamaria.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 8, 2022
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)