Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Seizures Frequency
研究概览
简要总结
The aim of this study is to investigate the effects of cathodal transcranial direct current stimulation in the management of seizures in subjects with focal refractory epilepsy.
详细描述
Hypothesis
Epilepsy is the most common neurological disorder globally, affecting approximately 50 million people worldwide. Of these, approximately 20% present with intractable or refractory epilepsy, where the frequency of seizures cannot be controlled adequately with anti-epileptic drugs (AEDs), leading to great neurobiological, cognitive, psychological and social consequences. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that can effectively modulate (up- or down-regulate) cortical excitability of targeted brain regions. It has the potential of downregulating the neuronal activity, through the cathodal stimulation of the epileptic focal area and thus, reducing the frequency of seizures. Previous studies have shown that cathodal tDCS is a safe and effective treatment modality of treatment to reduce the frequency of seizures in patients with refractory epilepsy. However, the level of evidence of its effects in the management of seizures frequency is still low. In the present work, the investigators aim to evaluate the effects of tDCS in the management of seizures in patients with refractory epilepsy and its impact on cognitive function and quality of life.
Objective
The main aim of this randomized controlled trial is to determine if cathodal tDCS is effective in reducing the frequency of seizures in refractory epilepsy and, to determine if this reduction will positively impact the participants cognitive status and quality of life.
Methods: This is a prospective, randomized, placebo-controlled, double-blind, single-center study. The participants in the study will be randomized to either the intervention - tDCS group or sham group. Each individual will undergo 15 consecutive sessions of real cathodal tDCS stimulation or sham-stimulation. The primary outcome measure will be the frequency of seizures, measured by a seizure diary; changes in interictal epileptiform discharges on the Electroencephalogram (EEG); and functional connectivity changes in the epilepsy focal area, measured by resting-state Functional Resonance Image (rs-fMRI). Secondary outcomes include quality of life and cognition. Outcome measures will be done prior to intervention; immediately after intervention, at 1 month-follow up and again at 3-months follow up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The tDCS machine is equipped with a sham option, determined by a code, that will not be disclosed to the participants, outcome assessor and principal investigator until the moment of data analysis. Randomization will be done through envelopes that will contain the codes of types of stimulation (real vs sham), which will be prepared by a third party.
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
- •confirmed diagnosis of focal refractory epilepsy
- •participants must be 18 years or older
- •must be on a stable medication regimen
- •seizures frequency equal or greater than 1 seizure/month
- •participants or their caregivers must be able to use a seizures diary
排除标准
- •participants younger than 18 years old
- •diagnosis of generalized epilepsy
- •participants who are still making changes to medication regimen
- •participants who are pregnant
- •participants who have any kind of intracranial implants
- •seizure frequency less than 1/month
- •participants with skin abnormalities or rash on the scalp
- •participants or caregivers that are unable to use a seizures diary
结局指标
主要结局
Seizures Frequency
时间窗: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
Seizure frequency will be measured through the data analysis of a seizures diary
Changes in interictal epileptiform discharges on the electroencephalogram (EEG)
时间窗: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
EEG study will be conducted to determine changes in epileptiform discharge
Changes in resting state connectivity through analysis of functional magnetic resonance imaging
时间窗: Pre-intervention, post-intervention, 1 month post-intervention and 3 months post-intervention
Resting state Functional Magnetic Resonance Image to determine changes in brain functional connectivity
次要结局
- Positive changes in quality of life(Pre-intervention, 1 month post-intervention, 3 months post-intervention)
- Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)(Pre-intervention, 1 month post-intervention, 3 months post-intervention)
研究者
Miriam Maria Pereira Novo
Principal Investigator
University of Campinas, Brazil