Back to resultsTranscranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
Primary Purpose
Refractory Frontal Lobe Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Frontal Lobe Epilepsy focused on measuring repetitive transcranial magnetic stimulation, low frequency, frontal lobe epilepsy, brain excitability, electromyography
Eligibility Criteria
Inclusion Criteria:
- Cryptogenic frontal lobe epilepsy
- Normal cerebral MRI
Sites / Locations
- Département de Neurologie - Hôpital Civil
- Institut de Physique Biologique
Outcomes
Primary Outcome Measures
Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.
Secondary Outcome Measures
Clinical efficacity on seizure intensity and frequency.
Full Information
NCT ID
NCT00382707
First Posted
September 28, 2006
Last Updated
August 29, 2011
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00382707
Brief Title
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
Official Title
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Frontal Lobe Epilepsy
Keywords
repetitive transcranial magnetic stimulation, low frequency, frontal lobe epilepsy, brain excitability, electromyography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.
Primary Outcome Measure Information:
Title
Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.
Secondary Outcome Measure Information:
Title
Clinical efficacity on seizure intensity and frequency.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cryptogenic frontal lobe epilepsy
Normal cerebral MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge CHASSAGNON, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Study Director
Facility Information:
Facility Name
Département de Neurologie - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut de Physique Biologique
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
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