Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (… (NCT02383407) | Clinical Trial Compass
CompletedNot Applicable
Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
United States6 participantsStarted 2013-12
Plain-language summary
The primary aim of the current proposal is to evaluate safety and tolerability, in terms of neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims include evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants are between the ages of 18 -65 years of age
* Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with unilateral or bilateral MTLE
* Participants must have tried and failed two trials of antiepileptic drugs (AEDs)
* Participants may have lesional or non lesional hippocampi, as evidenced by brain MRI acquired within the previous two years
* Participants are prescribed and taking 1-4 AEDs at the time of study entry
* Study participants will have intractable (MTLE) with a seizure frequency of at least 1/month averaged over the preceding 6 months prior to enrollment, including maximum seizure-freedom periods of no more than 60 days.
* Participants must have a platelet count greater than 125,000 per cubic millimeter and prothrombin time (PT) and activated partial thromboplastin time (aPTT) within normal limits at the visit prior to surgery
Exclusion Criteria:
* Progressive neurological or medical diseases, such as brain tumors or neurodegenerative disease or cancer
* Non-compliance with antiepileptic medications as demonstrated by the medical record
* Any conditions interfering with electrode implantation
* Any non-epileptic seizures
* Inability or unwillingness to complete neuropsychological tests or complete seizure diaries
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
* Pregnant, …
What they're measuring
1
Safety and Tolerability of Low Frequency Stimulation of the Fornix With Regards to Memory Function