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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06212609
Other study ID # PI2021_843_0215
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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