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CEEG Changes After Tdcs and Dual-task Training

Primary Purpose

Stroke, Electroencephalogram

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aging and Neuroscience Studies LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

m1 stimulation + dual task training

stimulation in M1 and DLPF + dual task training

sham stimulation + dual task training

Arm Description

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

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

Participants will receive simulated stimulation

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

Cognitive function - trail test (TMT) A and B
TMT consists of connecting letters in the order they appear in the alphabet (A tracks); or letters to numbers, also following the sequence in which they appear in the alphabet, for example, 1-A-2-B and so on (B tracks), with the possibility of evaluating the cognitive components of planning, organization, attention, perseverance and memory.
Cognitive function - clock drawing test
Currently, the RDT is widely used, it is simple to apply and quick to perform, which assesses several cognitive dimensions, such as memory, motor function, executive function and verbal comprehension. Regarding its score, the Shulman scale scores 5 points in total and a cut-off point equal to 3. The Mendez scale scores up to 20 points for the perfect design of the watch, with a cut-off point equal to 18 points.
Cognitive function - verbal fluency test (VF).
The VF test assesses several domains such as working memory, language, organizational skills and sequencing. In this test, the patient is asked to speak the largest number of words (within each required category). In the VF test, responses are scored, but repetitions are not considered.
motor function
The Timed Up and Go Test (TUG) test will be used

Full Information

First Posted
July 19, 2022
Last Updated
April 28, 2023
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT05492435
Brief Title
CEEG Changes After Tdcs and Dual-task Training
Official Title
Changes in EEG Microestates After Combined Treatment od Tdcs and Dual-task Training in Stroke Patients: a Cross-roads, Sham-controlled,Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Electroencephalogram

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
m1 stimulation + dual task training
Arm Type
Experimental
Arm Description
participants will receive real current over the primary motor area (M1)
Arm Title
stimulation in M1 and DLPF + dual task training
Arm Type
Experimental
Arm Description
participants will receive real current over the M1 and over the dorsolateral prefrontal area (DLPFC)
Arm Title
sham stimulation + dual task training
Arm Type
Sham Comparator
Arm Description
Participants will receive simulated stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in EEG microstates in each stimulation condition
Description
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)).
Time Frame
immediately after the sessions
Secondary Outcome Measure Information:
Title
Cognitive function - trail test (TMT) A and B
Description
TMT consists of connecting letters in the order they appear in the alphabet (A tracks); or letters to numbers, also following the sequence in which they appear in the alphabet, for example, 1-A-2-B and so on (B tracks), with the possibility of evaluating the cognitive components of planning, organization, attention, perseverance and memory.
Time Frame
immediately after the sessions
Title
Cognitive function - clock drawing test
Description
Currently, the RDT is widely used, it is simple to apply and quick to perform, which assesses several cognitive dimensions, such as memory, motor function, executive function and verbal comprehension. Regarding its score, the Shulman scale scores 5 points in total and a cut-off point equal to 3. The Mendez scale scores up to 20 points for the perfect design of the watch, with a cut-off point equal to 18 points.
Time Frame
immediately after the sessions
Title
Cognitive function - verbal fluency test (VF).
Description
The VF test assesses several domains such as working memory, language, organizational skills and sequencing. In this test, the patient is asked to speak the largest number of words (within each required category). In the VF test, responses are scored, but repetitions are not considered.
Time Frame
immediately after the sessions
Title
motor function
Description
The Timed Up and Go Test (TUG) test will be used
Time Frame
immediately after the sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LETICIA MARIA
Phone
81 993684588
Email
leticiamaria.fisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, Dra
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aging and Neuroscience Studies Laboratory
City
João Pessoa
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade

12. IPD Sharing Statement

Plan to Share IPD
No

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CEEG Changes After Tdcs and Dual-task Training

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