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Taking people in FranceNo phase

Tests brain stimulation with a personalized electrical current for hard-to-treat epilepsy

Tests electrical brain stimulation in children with drug-resistant epilepsy.

Plain-language title generated from the registry record
Registry title: Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies

Key facts

Where
Amiens, FranceSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 18 years old?

Source: NCT06212609, who can take part

Where in France

  • CHU AmiensAmiens, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Centre Hospitalier Universitaire, Amiens
Trial code
NCT06212609
Record updated
31 January 2024
Original description
Epilepsy is one of the most common neurological diseases, affecting between 0.5% and 1% of the general population. Therefore, new diagnostic and treatment methods are having a big impact on society. Epilepsy is also one of the most commonly diagnosed pediatric neurological disorders, with long-term implications for the quality of life of those affected and their relatives. In only two-thirds of cases, seizures can be adequately controlled with anticonvulsant drug therapy. For other patients with a drug-resistant focal epilepsy (up to around 2 million in Europe) epilepsy surgery is currently the most effective treatment. However, only 15-20% of these drug-resistant patients are eligible for epilepsy surgery. This is either because the cortical epileptogenic zone cannot be localized with sufficient precision with standard diagnostic means, or because the epileptogenic zone overlaps meaningful cortical areas, so that it cannot be surgically removed without considerable neurological deficit.Read full original descriptionShow less

Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies

Epilepsy is one of the most common neurological diseases, affecting between 0.5% and 1% of the general population. Therefore, new diagnostic and treatment methods are having a big impact on society. Epilepsy is also one of the most commonly diagnosed pediatric neurological disorders, with long-term implications for the quality of life of those affected and their relatives. In only two-thirds of cases, seizures can be adequately controlled with anticonvulsant drug therapy. For other patients with a drug-resistant focal epilepsy (up to around 2 million in Europe) epilepsy surgery is currently the most effective treatment. However, only 15-20% of these drug-resistant patients are eligible for epilepsy surgery. This is either because the cortical epileptogenic zone cannot be localized with sufficient precision with standard diagnostic means, or because the epileptogenic zone overlaps meaningful cortical areas, so that it cannot be surgically removed without considerable neurological deficit.

Inclusion: Any patient, male or female aged 1 to 18, with refractory partial epilepsy considered potentially surgical according to the definition of ILAE. Drug-resistant epilepsy can be defined as the failure of adequate therapeutic trials of two antiepileptics (either monotherapy or in combination) so that the patient is free from seizures on a lasting basis; Any epileptic patient with interictal epileptic spikes on his standard or High Resolution EEG and or on the Magnetoencephalography examination; Any epileptic patient undergoing a structural MRI; Any patient who has agreed to participate in the PerEpi 1 study allowing the optimization of the location of epileptic sources and the modelling of the optimization of the parameters of transcranial electrical stimulation; Patients who have at least 4 seizures per month.

Exclusion: And/or presenting generalized epilepsy; And/or presenting diffuse interictal peaks and/or presenting a serious alteration of the general condition and vital functions; Contraindication to the use of mc-tDCS stimulation without seizure; Patient not meeting the age criteria; And/or in the event of refusal by one of the parents or the child; Pregnant, parturient or breastfeeding woman.

ClinicalTrials.gov NCT06212609