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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Safety and Tolerability of Low Frequency Stimulation of the Fornix With Regards to Memory Function
The primary outcome is safety and tolerability of LFSF in participants with intractable MTLE with regards to memory function. The number of participants listed are those who had a significant changes in RAVLT score.
Time frame: 1 year
Psychiatric Health (Effects of LFS on Psychiatric Symptoms Using Standardized Measures That Are Known to be Sensitive to Changes to Surgical Treatment of TLE)
Since LFSF is expected to activate limbic structures, we will assess the effects of LFS on psychiatric symptoms using standardized measures that are known to be sensitive to changes to surgical treatment of TLE. The number of participation listed are those who had a significant change in anxiety, depression, or suicidality based on a qualitative overview of the psychiatric assessments performed preoperatively and postoperatively.
Time frame: 1 year
To Assess if Electrode Implantation in the Fornix is Feasible as is Done in Patients With Parkinson's Disease.
The DBS leads are routinely implanted for patients with Parkinson's disease. Thus, we planned to implant Model 3389 DBS leads using the same technique of stereotactic implantation. A secondary aim of this trial is to standardize the implantation, the evoked potential and electric current determination procedures in preparation for a large-scale phase III trial. The number of participants with the outcome measure are those in whom bilateral hippocampal CCEPs were consistently present.
Time frame: 1 year
Effect on Seizure Frequency
Seizure reduction: Subjects underwent implantation of pulse generators and long-term low-frequency stimulation with mean monthly seizures during blinded phase
Time frame: 1 year
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