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

Epilepsy Clinical Trial

— PerEpi2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212609
• Other study ID #: PI2021_843_0215
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Wallois, Pr
• Phone: 03 22 087775
• Email: fabrice.wallois[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Drug Resistant Epilepsy
• Epilepsy
• tDCS

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of remaining seizure number	evaluation a new procedure of non-invasive, individualized and optimized transcranial electrical stimulation therapy in the management of pharmaco-resistant focal epilepsies during a study allowing to identify a "proof of concept", in particular for patients who are not eligible for epilepsy surgery	10 weeks