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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.
Full description
Low frequency stimulation is an attractive, uninvestigated method for treatment of intractable epilepsy. Preliminary animal and human data suggest safety and remarkable efficacy of Low frequency stimulation (LFS) in epilepsy. In addition, the duty cycle of LFS is very low, implying less electric current injection, with less charge density on the target tissue and electrodes, and longer battery life. The current project is a classic translational, single-blinded, randomized research project, demonstrating a clear path from the laboratory to bedside. If successful, this new therapy will be of great value to patients with medically and surgically intractable Mesial Temporal Lobe Epilepsy (MTLE).
The study is expected to last approximately 5 years, from enrollment of the first patient to completion of the final subject, taking into consideration attrition and otherwise-eligible subjects who will not elect to participate. Once the study is completed, and enrolled participants have completed all required elements of the protocol, a final report will be submitted to the FDA. Participants may also discontinue their participation in the study, if they wish, at any time.
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Inclusion criteria
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, or planning to become pregnant*
Participation in another research trial where the participant was treated with another investigational drug or device within 30 days prior to enrollment of study
Intelligence Quotient showing a general ability Quotient of less than 70. The score excludes the contribution of working memory and processing speed (which are areas of cognitive functioning that are vulnerable to numerous influences including seizures and fatigue and effects of AEDs)
Inability or unwillingness of individual to give written informed consent
Participants who have changes to their antiepileptic medications during the baseline phase (as they will need to repeat the baseline phase)
Subjects with history of status epilepticus within the preceding year
History of psychiatric illness necessitating hospitalizations
Subjects who have any of the following implanted devices: aneurysm clips, cardiac pacemaker or defibrillator, cochlear implant, spinal cord, DBS, or vagal nerve stimulator
Co-morbid conditions that would interfere with study stimulation activities or response to treatment, which may include:
Primary purpose
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6 participants in 2 patient groups
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Central trial contact
Mohamad Z. Koubeissi, MD
Data sourced from clinicaltrials.gov
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