- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06212609
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies (PerEpi2)
January 30, 2024 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fabrice Wallois, Pr
- Phone Number: 03 22 087775
- Email: fabrice.wallois@u-picardie.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Fabrice Wallois, Pr
- Phone Number: (33)322087775
- Email: fabrice.wallois@u-picardie.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
January 9, 2024
First Submitted That Met QC Criteria
January 9, 2024
First Posted (Actual)
January 19, 2024
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2021_843_0215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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