Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Brain symmetry (baseline)
研究概览
简要总结
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.
详细描述
After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.
All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 3 months after stroke;
- •Ischemic or hemorrhagic stroke with upper limb motor impairment;
排除标准
- •Any contraindication for application of transcranial magnetic stimulation;
- •Peripheral lesions in the assessed upper limb;
- •Score ≤ 18 at Folstein Mini Mental State Examination;
- •Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
- •Application of botulinum toxin in less than 6 months.
结局指标
主要结局
Brain symmetry (baseline)
时间窗: Before each session (10 sessions for 5 days a week for two weeks)
Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (\> 4 a ≤ 8 Hz); alpha (\> 8 a ≤13 Hz); beta (\> 13 a ≤ 30 Hz); gama (\< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Brain symmetry (post-treatment)
时间窗: After each session (10 sessions for 5 days a week for two weeks)
Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (\> 4 a ≤ 8 Hz); alpha (\> 8 a ≤13 Hz); beta (\> 13 a ≤ 30 Hz); gama (\< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
次要结局
- Change in Fugl Meyer assesment of paretic upper limb motor function(10 sessions (5 days a week for two weeks))
- Modified Ashworth Scale(10 sessions (5 days a week for two weeks))
- The National Institutes of Health Stroke(10 sessions (5 days a week for two weeks))
研究者
Kátia Monte-Silva
Clinical professor
Universidade Federal de Pernambuco