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NCT Number: NCT06212609

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.

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Key information

Conditions

Transcranial Electric Stimulation Brain Diseases Central Nervous System Diseases Children Epilepsy HR EEG Nervous System Diseases Pharmacoresistant tDCS

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial electrical stimulation therapy

Other

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

Primary outcomes

  1. Change from baseline of remaining seizure number

    Time frame: 10 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice Wallois, Pr

CONTACT

[email protected]

03 22 087775

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PerEpi2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 19, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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