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

NCT ID: NCT04752800

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-12-31

Brief Summary

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.

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.

Conditions

Stroke

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Direct Current Transcranial Stimulation - tDCS

Intervention Type: DEVICE

Intervenção Ativa

Sham tDCS

The protocol for placebo stimulation will be identical, but the device will stop emitting current 30 seconds after the start of stimulation.

Group Type: SHAM_COMPARATOR

Sham Intervention

Intervention Type: DEVICE

Direct Current Transcranial Stimulation - Sham Intervention

Interventions

Direct Current Transcranial Stimulation - tDCS

Intervenção Ativa

Intervention Type: DEVICE

Sham Intervention

Direct Current Transcranial Stimulation - Sham Intervention

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Suellen Marinho Andrade

Principal Researcher and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suellen Andrade

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

Central Contacts

Suellen Andrade

Role: CONTACT

suellenandrade@gmail.com

83 99937-1471

Letícia Maria

Role: CONTACT

leticiamaria.fisio@gmail.com

81 99368-4588

Other Identifiers

EEGtDCSAVC

Identifier Type: -

Identifier Source: org_study_id