Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies (PerEpi2)

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Epilepsy
Transcranial Electric Stimulation
Pharmacoresistant
Children
tDCS
HR EEG

Treatments

Other: transcranial electrical stimulation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06212609
PI2021_843_0215

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Fabrice Wallois, Pr

Data sourced from clinicaltrials.gov

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