Refractory Frontal Lobe EpilepsyNCT00382707
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
A study testing cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull. in people with Refractory Frontal Lobe Epilepsy, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Refractory Frontal Lobe Epilepsy
- What is being tested?
- cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- May 2006to Aug 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cryptogenic frontal lobe epilepsy
- Normal cerebral MRI
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Département de Neurologie - Hôpital Civil
Strasbourg, 67091
Institut de Physique Biologique
Strasbourg, 67091
About this study
Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.
- Conditions
- Refractory Frontal Lobe Epilepsy
- Being tested
- cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.
- Keywords
- repetitive transcranial magnetic stimulation, low frequency, frontal lobe epilepsy, brain excitability, electromyography
- Medical subject headings
- Epilepsy, Frontal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.
Secondary outcomes (1)
Clinical efficacity on seizure intensity and frequency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startMay 2006
- Primary completion1 Sep 2009
- Study completionAug 2011
Why it stopped: Premature termination following the departure of the principal investigator. No replacement investigator. Management decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Frontal Lobe EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge CHASSAGNON, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382707
- Sponsor's protocol ID
- 3540
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2006
- Last updated
- 1 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
- ClinicalTrials.gov ID
- NCT00382707
- Acronym / sponsor ID
- 3540
- Conditions
- Refractory Frontal Lobe Epilepsy
- Keywords
- repetitive transcranial magnetic stimulation, low frequency, frontal lobe epilepsy, brain excitability, electromyography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination following the departure of the principal investigator. No replacement investigator. Management decision.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- 1 Sep 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Sep 2006 (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.
Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cryptogenic frontal lobe epilepsy
- Normal cerebral MRI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull. | Device | – |
Primary outcome
Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.
1 secondary outcome
Clinical efficacity on seizure intensity and frequency.
Results and safety
The study was stopped early (reason given: Premature termination following the departure of the principal investigator. No replacement investigator. Management decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
Serge CHASSAGNON, MD study director
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull. in people with Refractory Frontal Lobe Epilepsy, run by University Hospital, Strasbourg, France at 2 sites 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Premature termination following the departure of the principal investigator. No replacement investigator. Management decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.. 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 1 Oct 2025.