EpilepsyStiMiCNCT03738072
Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy
A study testing StiMiC stimulation condition in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- StiMiC stimulation condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2018to Dec 2026
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.
Who cannot join
- usual excluding criteria for a SEEG.
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 de Toulouse
Toulouse, 3100
Jonathan Curot, MD, curot.j@chu-toulouse.fr
Marie Denuelle, MD, denuelle.m@chu-toulouse.fr
About this study
Official title: A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)
Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.
Read the detailed description
Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies.
This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe).
The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.
- Conditions
- Epilepsy
- Being tested
- StiMiC stimulation condition
- Keywords
- Epilepsy, Electrical Brain stimulation, Neurosurgery, stereo-electro-encephalography (SEEG)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiMiC stimulation conditionDiagnostic test
This new condition of stimulation of electrical Brain Stimulation will be evaluate to determine if this stimulation is more efficient that standard stimulation condition
| Study group | Role | What they receive |
|---|---|---|
| StiMic stimulation condition | Experimental | StiMic stimulation condition will be evaluate during stereo-electro-encephalography and this condition will be compare to standard stimulation condition Receives: Diagnostic Test: StiMiC stimulation condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition
Comparison for each patient of the index of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect over the total number of stimulations) for each condition (standard clinical stimulations condition vs research stimulations condition).
Measured: 22 days after implantation of electrode
Secondary outcomes (4)
efficient stimulation for each frequency of stimulation
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each frequency of stimulation.
Measured: 22 days after implantation of electrode
efficient stimulation for each type of brain area stimulated
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each type of brain area stimulated (i.e, anatomical brain area, seizure onset zone, primary seizure propagation zone, healthy brain area or lesion).
Measured: 22 days after implantation of electrode
percentage change in the neuronal discharge rate
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the frequency of stimulations.
Measured: 30 second after stimulation
percentage change in the neuronal discharge rate for stimic stimulation condition
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the effect of the stimulation (electrical or clinical as defined in the primary outcome)
Measured: 30 second after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start14 Nov 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Curot, MD, Principal investigator, CHU of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738072
- Sponsor's protocol ID
- RC31/17/0345
- Acronym
- StiMiC
- Status last verified
- May 2026
- First submitted
- 8 Nov 2018
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)
- ClinicalTrials.gov ID
- NCT03738072
- Acronym / sponsor ID
- StiMiC / RC31/17/0345
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Electrical Brain stimulation, Neurosurgery, stereo-electro-encephalography (SEEG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2018 (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.
Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.
Detailed description
Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies.
This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe).
The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StiMic stimulation condition | Experimental | Diagnostic Test: StiMiC stimulation conditionStiMic stimulation condition will be evaluate during stereo-electro-encephalography and this condition will be compare to standard stimulation condition |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.
Key exclusion criteria (1 listed)
- usual excluding criteria for a SEEG.
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 |
|---|---|---|
| StiMiC stimulation conditionThis new condition of stimulation of electrical Brain Stimulation will be evaluate to determine if this stimulation is more efficient that standard stimulation condition | Diagnostic test | StiMic stimulation condition |
Primary outcome
Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition
Time frame: 22 days after implantation of electrode
Comparison for each patient of the index of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect over the total number of stimulations) for each condition (standard clinical stimulations condition vs research stimulations condition).
4 secondary outcomes
efficient stimulation for each frequency of stimulation
Time frame: 22 days after implantation of electrode
efficient stimulation for each type of brain area stimulated
Time frame: 22 days after implantation of electrode
percentage change in the neuronal discharge rate
Time frame: 30 second after stimulation
percentage change in the neuronal discharge rate for stimic stimulation condition
Time frame: 30 second after stimulation
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 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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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.
Jonathan Curot, MD principal investigator
CHU of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StiMiC stimulation condition in people with Epilepsy, run by University Hospital, Toulouse 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 1 inclusion and 1 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 7 May 2026. 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 Jonathan Curot, MD (05 61 77 56 08 ext. 33, curot.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition (time frame: 22 days after implantation of electrode). 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 7 May 2026.