Epilepsy Intractable Clinical Trial
Official title:
Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy
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.
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.
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