NCT06212609Recruiting
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
Source: ClinicalTrials.gov · Last updated 31 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Epilepsy
- NCT number
- NCT06212609
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Dec 2023 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- And/or presenting generalized epilepsy
- And/or presenting diffuse interictal peaks and/or presenting a serious alteration of the general condition and vital functions
- Contraindication to the use of mc-tDCS stimulation without seizure
Age
- Patient not meeting the age criteria
Other
- And/or in the event of refusal by one of the parents or the child
- Pregnant, parturient or breastfeeding woman.
Who the study is looking for
- 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
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.