Clinical trial NCT04752800: Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke
Official title: Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke: Sham Controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Transcranial direct current stimulation
Functional Connectivity
Motor function
Quality of life
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, sham-controlled clinical trial will be carried out involving patients with ischemic stroke in the initial subacute stage, submitted to transcranial direct current stimulation sessions. This study will obey the SPIRIT guidelines, which is considered a guideline composed of minimum contents of a clinical trial protocol
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Motor function
timeFrame: Baseline and after 3 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline and after 3 weeks
measure: Functional Connectivity
timeFrame: Baseline and after 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Paraiba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References: