New Remedies Ltd
Liverpool, Merseyside, L1 0AH, United Kingdom
NCT Number: NCT05825274
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. It encompass a wide spectrum of conditions, intensities and seizure types; therefor, several drugs have proven to treat different types of seizures. However, around 22.5 % of patients are unable to attain control regardless of the drug used or even a combination of several of them. TDCs offers a non-invasive approach with a focal effect for those patients. The focus of this study is to define the role for tDCS in the treatment of drug-resistant epilepsy on children.
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Notify Me18 month–120 month
All sexes
Interventional
Not applicable
Liverpool, Merseyside, L1 0AH, United Kingdom
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. There are between 16 and 51 new cases per 100 000 people every year. A community-based study conducted in France concluded that up to 22.5 % of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial disfunction and a reduced quality of life. The International League against Epilepsy defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients are the drive to develop different approaches in order to offer alternatives for control. In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarisation shifts, an enhanced probability of high-frequent and hypersyncronous activity of small neuronal networks and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal conections. Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repidetly, it generates long-lasting cortical excitability alterations and thus, has the potential to treat epilepsy targeting to the specific brain region where the cortical excitability is alterated. The aim of this study is to define the role for tDCS on the treatment of drug resistant epilepsy on children.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus
Other names: Brain Noninvasive Electrical Stimulation, tDCS
Time frame: 4 months
Improve epilepsy and EEG (NO statistically and clinically significant spikes or slow waves were observed in EEG)., and changes in scale: QUALITY OF LIFE IN EPILEPSY - QOLIE-31
Time frame: 4 Months
kg / m^2
Time frame: 4 months
less drugs consum and number of crisis per week, or moderate changes in EEG or brainwaves
Time frame: 4 Months
During each assessment session, occupational therapists measured patients' functions with the KF-NAP, Functional Independence Measure (FIM™) and Barthel Index (BI)
Spanish Foundation for Neurometrics Development
Other
Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children
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