Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke

Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke: Sham Controlled, Randomized Clinical Trial

A randomized, double-blind, sham-controlled clinical trial will be conducted with 30 people with stroke, recruited at a referral hospital in João Pessoa. After recruitment they will be randomized into two groups: Group 1 - active stimulation and group - 2 sham stimulation. Participants will receive 10 sessions of ETCC, for 20 minutes, on alternate days (3 times a week), where the electrodes will be positioned over the primary motor cortex. 3 minutes of EEG at rest will be taken from each participant, and they will be instructed not to be actively involved in any cognitive or mental activity. In the first and last meetings, evaluations will be carried out, the outcomes evaluated will be: motor function, quality of life and functional connectivity.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Direct Current Transcranial Stimulation - tDCS; Device: Sham Intervention

Detailed Description

Previous studies analyzed by systematic reviews suggest that the effects of ETCC may vary between subjects, where some stroke patients may not receive any additional benefits from therapy. Thus, it is necessary to use a biomarker that manages to elect those who will possibly benefit from the electric current. Therefore, the objective of this study is to investigate whether the EEG measures of functional connectivity of the target network of the stimulation are associated with the response to ipsilesional anodic ETCC in patients with stroke in the late subacute phase. as well as to observe if these findings can be associated with a clinical improvement of the patient. For that, a randomized, double-blind, sham-controlled clinical trial will be carried out with 30 people with stroke, recruited at a referral hospital in joão Pessoa.

After recruitment they will be randomized into two groups: Group 1 - active stimulation and group - 2 sham stimulation. Participants will receive 10 sessions of ETCC, for 20 minutes, on alternate days (3 times a week), where the electrodes will be positioned over the primary motor cortex. 3 minutes of EEG at rest will be taken from each participant (Eyes open and eyes closed), and they will be instructed not to be actively involved in any cognitive or mental activity. In the first and last meetings, evaluations will be carried out, the outcomes assessed will be: motor function, quality of life and functional connectivity.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suellen Andrade; Phone Number: 83 99937-1471; Email: suellenandrade@gmail.com
• Study Contact Backup: Name: Letícia Maria; Phone Number: 81 99368-4588; Email: leticiamaria.fisio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have had a single episode of unilateral, ischemic stroke, in middle cerebral artery proven by means of magnetic resonance imaging or computed tomography;
• Young adult individuals, over 18 years old;
• Both sexes;
• Patients in late subacute stage. Late sub-acute stage will be considered for patients between 3 and 6 months after stroke;
• Mild to moderate patients with a Fugl-Meyer score >85 points;
• Patients with mild to moderate degree of injury severity (NIHHS <17 points);
• Presentation of up to 4 points on the Rankin scale.

Exclusion Criteria:

• 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;
• Epilepsy history report; gestation; people with traumatic brain injury or tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS; Participants will receive 10 ETCC sessions, for 20 minutes, on alternate days (3 times a week). The electrodes will be positioned on the primary motor cortex (position C3 or C4 according to the international electroencephalogram system - EEG 10/20), with the anode positioned on the affected hemisphere and the cathode on the supraorbital region in the hemisphere contralateral to the injury. The electrodes will be wrapped with sponges of 5 x 7 cm and moistened with saline (NaCl 0.9%). The current intensity will be 2mA.	Device: Direct Current Transcranial Stimulation - tDCS; Intervenção Ativa
Sham Comparator: Sham tDCS; The protocol for placebo stimulation will be identical, but the device will stop emitting current 30 seconds after the start of stimulation.	Device: Sham Intervention; Direct Current Transcranial Stimulation - Sham Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor function	For the analysis of the primary outcome, the fulgl-Meyer evaluation scale will be used. The scale consists of a cumulative numerical scoring system that assesses aspects related to range of motion, pain, sensitivity, motor function of the upper and lower extremities, in addition to coordination and speed.	Baseline and after 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	To assess quality of life, the SF-36 questionnaire will be used, which is a multidimensional instrument, easy to administer and understand, translated and validated in Brazil, consisting of 36 items, encompassed in 8 scales: functional capacity, physical aspects, pain, state general health, vitality, social aspects, emotional aspects and mental health. It has a maximum final score of 100 points, where the higher the score, the greater the health status.	Baseline and after 3 weeks
Functional Connectivity	For the EEG record, the actiCHamp32 model, Brain Products GmbH®, with 32 electrodes will be used. During data collection, participants will be seated in a comfortable chair, where they will be instructed to keep their gaze turned to a fixation point, avoiding talking or moving, these measures will be adopted to try to minimize the possible artifacts that may exist in the EEG record. Participants will also be instructed not to engage in any cognitive or mental activity during the collection period. The data will be collected in an environment conducive to the acquisition (silent place, with adequate lighting) where only the participant and the researcher responsible for the collection will be present.	Baseline and after 3 weeks

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Quality of life; Transcranial direct current stimulation; Motor function; Functional Connectivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: EEGtDCSAVC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No