Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke: Sham Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Motor function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Motor function
时间窗: Baseline and after 3 weeks
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.
次要结局
- Change in quality of life(Baseline and after 3 weeks)
- Functional Connectivity(Baseline and after 3 weeks)
研究者
Suellen Marinho Andrade
Principal Researcher and Professor
Federal University of Paraíba