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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory Epilepsy Group | Experimental | 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 |
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| Placebo Patients | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cathodal tDCS | Device | We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus |
|
| 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 |
| 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 (FIMâ„¢) and Barthel Index (BI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Neville, MD | New Remedies Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Remedies Ltd | Liverpool | Merseyside | L1 0AH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21885255 | Result | Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in refractory continuous spikes and waves during slow sleep: a controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5. doi: 10.1016/j.eplepsyres.2011.07.016. Epub 2011 Aug 31. | |
| 29312132 | Result |
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neuroterapias.es is the database where our foundation recorda all the clinical data of our assays
4 Months
login and password previous registration in neuroterapias.es
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
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we use in half of patient cathodal tDCS or Brain noninvasive stimulation
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| 4 Months |
| Strzelczyk A, Griebel C, Lux W, Rosenow F, Reese JP. The Burden of Severely Drug-Refractory Epilepsy: A Comparative Longitudinal Evaluation of Mortality, Morbidity, Resource Use, and Cost Using German Health Insurance Data. Front Neurol. 2017 Dec 22;8:712. doi: 10.3389/fneur.2017.00712. eCollection 2017. |
| 24791078 | Result | Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |