Status:
TERMINATED
A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of Western Ontario, Canada
University of Toronto
Conditions:
Temporal Lobe Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary goal is to determine whether hippocampal electrical stimulation (HS) is safe and more effective than simply implanting an electrode in the hippocampus without electrical stimulation (HI), ...
Detailed Description
This is a multicentre, parallel-group, double blind randomized controlled trial involving patients with MTLE who may be candidates for resective surgery or whose memory function precludes resective su...
Eligibility Criteria
Inclusion
- Unilateral or Bilateral Mesial Temporal lobe Epilepsy.
- Age ≥ 18 years.
- Global IQ ≥70.
- Failure of ≥ 2 AEDs approved for treatment of partial seizures, used alone or in combination at recommended dosages.
- Average ≥ 3 seizure-days per month in prior 6 months during which disabling seizures occurred. Disabling seizures are defined as complex partial seizures with or without secondary generalization, or as simple partial seizures that are noticeable by others or interfere with function.
- Ability to complete self-administered questionnaires.
- Availability of reliable collateral historian or witness.
- Patient preference for non-resective surgery, or not a candidate for mesial temporal resection.
- Give written informed consent.
Exclusion
- Extratemporal or multifocal epilepsy.
- MRI evidence of potentially epileptogenic lesions outside the mesial temporal region.
- Lesions precluding electrode implantation (eg, vascular malformations, vascular tumors).
- Severe hippocampal sclerosis that in the surgeon's opinion precludes accurate electrode placement.
- Brain lesions that demand prompt surgical therapy (eg, malignant tumors, vascular malformations).
- Progressive neurological disorders (eg, malignant tumor, dementia, degenerative disorders).
- Medical or psychiatric conditions precluding surgery or interfering with adherence to treatment and follow-up.
- Planned pregnancy during the study. Women of child-bearing age will require a negative pregnancy test and adequate contraception methods.
- Ongoing or planned participation in other studies of new epilepsy therapies.
- Contraindication for stereotactic surgery, e.g. bleeding diathesis, anticoagulants, treatment with valproate at the time of surgery (risk of bleeding).
- Any condition that would make participation in the trial detrimental to the patient's health.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00717431
Start Date
January 1 2008
End Date
March 1 2012
Last Update
April 2 2012
Active Locations (1)
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1
Foothills Medical Centre, Clinical Neurosciences
Calgary, Alberta, Canada