TDCs to Treat Drug-resistant Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children

Conditions
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Other Forms of Epilepsy, Treatment Resistant

Intervention / Treatment
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* Device: Cathodal tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 montths Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose. At least 2-3 seizure per month documented with EEG, not only clinically. In good health except epilepsy. Patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up. Exclusion Criteria: Results of MRI remind epilepsy caused by intracranial space-occupying lesions. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication sleep-related breathing disorders

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 120 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refractory Epilepsy Group<br>50 patients with at least they have 3 crisis per week They Receive Cathodal tDCS We do EEG before and after intervention with 19 channels and the patient complete questionnarie: QUALITY OF LIFE IN EPILEPSY - QOLIE-31 | Device: Cathodal tDCS<br>* We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus<br>* Other names: tDCS;|
| Placebo Comparator: Placebo Patients<br>50 patients with at least they have 3 crisis per week that receive SHAM They Not Receive Cathodal tDCS. We do EEG before and after intervention with 19 channels and the patient complete questionnarie: QUALITY OF LIFE IN EPILEPSY - QOLIE-31 | Device: Cathodal tDCS<br>* We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in number of crisis per day | 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 | 4 months | 
| Body mass index | kg / m^2 | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality live improve | less drugs consum and number of crisis per week, or moderate changes in EEG or brainwaves | 4 months | 
| Kessler Foundation Neglect Assessment Process | During each assessment session, occupational therapists measured patients' functions with the KF-NAP, Functional Independence Measure (FIM™) and Barthel Index (BI) | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, Drug-resistant epilepsy