Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825274
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2017-09-14
Brief Title:
TDCs to Treat Drug-resistant Epilepsy
Sponsor:
Spanish Foundation for Neurometrics Development
Organization:
Spanish Foundation for Neurometrics Development
Study Overview
Official Title:
Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 225 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:
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 225 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None