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RecruitingNCT06212609PerEpi2Updated Jan 31, 2024

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

An interventional study of transcranial electrical stimulation therapy in Transcranial Electric Stimulation, tDCS and Epilepsy, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Transcranial Electric Stimulation
  • tDCS
  • Epilepsy
  • Pharmacoresistant
  • HR EEG
  • Children

Keywords

  • Transcranial electric stimulation
  • tDCS
  • Epilepsy
  • pharmacoresistant
  • HR EEG
  • children
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • Othertranscranial electrical stimulation therapy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06212609
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jan 19, 2024
Start date
Dec 1, 2023
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jan 31, 2024

Study contacts

Fabrice Wallois, Pr
Contact
fabrice.wallois@u-picardie.fr
03 22 087775

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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