Transcranial Electric StimulationPerEpi2NCT06212609
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
A study testing transcranial electrical stimulation therapy in people with Transcranial Electric Stimulation and tDCS, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Transcranial Electric Stimulation, tDCS, Epilepsy
- What is being tested?
- transcranial electrical stimulation therapy
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Fabrice Wallois, Pr, (33)322087775, fabrice.wallois@u-picardie.fr
About this study
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.
- Conditions
- Transcranial Electric Stimulation, tDCS, Epilepsy, Pharmacoresistant, HR EEG, Children
- Being tested
- transcranial electrical stimulation therapy
- Keywords
- Transcranial electric stimulation, tDCS, Epilepsy, pharmacoresistant, HR EEG, children
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulation therapyOther
new procedure of non-invasive, individualized and optimized transcranial electrical stimulation therapy in the management of pharmaco-resistant focal epilepsies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Electric StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212609
- Sponsor's protocol ID
- PI2021_843_0215
- Acronym
- PerEpi2
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
- ClinicalTrials.gov ID
- NCT06212609
- Acronym / sponsor ID
- PerEpi2 / PI2021_843_0215
- Conditions
- Transcranial Electric Stimulation, tDCS, Epilepsy, Pharmacoresistant, HR EEG, Children
- Keywords
- Transcranial electric stimulation, tDCS, Epilepsy, pharmacoresistant, HR EEG, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial electrical stimulation therapynew procedure of non-invasive, individualized and optimized transcranial electrical stimulation therapy in the management of pharmaco-resistant focal epilepsies | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical stimulation therapy in people with Transcranial Electric Stimulation and tDCS, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Wallois, Pr (03 22 087775, fabrice.wallois@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of remaining seizure number (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.