Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 protocolMasking: Double (Participant, Outcomes Assessor)Masking Description: Participants will be divided into 02 groups: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants will be included in the study using the eligibility criteria and will be randomly allocated, in 1: 1 blocks, where a random number generator will be used through an online randomization program (www.random.org). All researchers responsible for the evaluation before and after consultations will be blind to the type of treatment that the patient will receive (active stimulation or sham stimulation). The effectiveness of the masking mechanism will be assessed at the time of the last interview with the patients, when they will be asked about their opinions as to whether the electric current producing system was on or off.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 electri...
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 60 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 assessed will be: motor function, quality of life and functional connectivity.
Tracking Information
- NCT #
- NCT04752800
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Suellen Andrade Federal University of Paraiba
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