Focal EpilepsyPPNCT02245061
Cortical Excitability Assessment Using Paired Pulses
A study testing paired pulses cortical electrical stimulation in people with Focal Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- paired pulses cortical electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2014to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording
- Provide written consent to the study after receiving clear information
- Be a beneficiary or member of health insurance plan
Who cannot join
- Patient with contraindication for MRI scanning
- Pregnancy
- Prohibition on participation in other research, apart from any other non-interventional research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital neurologique de Lyon
Lyon, 69003
Sylvain RHEIMS, MD, 4 17 30 60 64 ext. +33, sylvain.rheims@chu-lyon.fr
About this study
Official title: Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography
The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.
However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.
The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.
- Conditions
- Focal Epilepsy
- Being tested
- paired pulses cortical electrical stimulation
- Keywords
- pharmacoresistant focal epilepsy, cortical excitability, paired pulses, TMS, SEEG, DES
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paired pulses cortical electrical stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| paired pulses cortical electrical stimulation | Experimental | Not described Receives: Other: paired pulses cortical electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)
Measured: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Secondary outcomes (2)
Presence of a difference of responses patterns between anatomic regions and/or lesion type
Measured: between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations
Measured: Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start9 Sep 2014
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245061
- Sponsor's protocol ID
- 2014.865
- Other IDs
- 2014-A00495-42
- Acronym
- PP
- Status last verified
- Oct 2019
- First submitted
- 9 Sep 2014
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography
- ClinicalTrials.gov ID
- NCT02245061
- Acronym / sponsor ID
- PP / 2014.865
- Conditions
- Focal Epilepsy
- Keywords
- pharmacoresistant focal epilepsy, cortical excitability, paired pulses, TMS, SEEG, DES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- 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.
The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.
However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.
The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paired pulses cortical electrical stimulation | Experimental | Other: paired pulses cortical electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years old
- Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording
- Provide written consent to the study after receiving clear information
- Be a beneficiary or member of health insurance plan
Key exclusion criteria (3 listed)
- Patient with contraindication for MRI scanning
- Pregnancy
- Prohibition on participation in other research, apart from any other non-interventional research
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 |
|---|---|---|
| paired pulses cortical electrical stimulation | Other | paired pulses cortical electrical stimulation |
Primary outcome
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
Time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)
2 secondary outcomes
Presence of a difference of responses patterns between anatomic regions and/or lesion type
Time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations
Time frame: Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paired pulses cortical electrical stimulation in people with Focal Epilepsy, run by Hospices Civils de Lyon 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain RHEIMS, MD (4 17 30 60 64 ext. +33, sylvain.rheims@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex (time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)). 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 23 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.