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

NCT ID: NCT06212609

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

Transcranial Electric Stimulation; tDCS; Epilepsy; Pharmacoresistant; HR EEG; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

transcranial electrical stimulation therapy

new procedure of non-invasive, individualized and optimized transcranial electrical stimulation therapy in the management of pharmaco-resistant focal epilepsies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabrice Wallois, Pr

Role: CONTACT

fabrice.wallois@u-picardie.fr

03 22 087775

Facility Contacts

Fabrice Wallois, Pr

Role: primary

fabrice.wallois@u-picardie.fr

(33)322087775

Other Identifiers

PI2021_843_0215

Identifier Type: -

Identifier Source: org_study_id