NCT04752800

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Direct Current Transcranial Stimulation - tDCS	Intervenção Ativa
DEVICE	Sham Intervention	Direct Current Transcranial Stimulation - Sham Intervention

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2021-02-12
• Last updated: 2022-05-09