Clinical Trial: Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)

Brief 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.

Detailed Summary:

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.


Sponsor: George Washington University

Current Primary Outcome: Safety and tolerability of low frequency stimulation of the fornix with regards to memory function [ Time Frame: 1 year ]

The primary outcome is safety and tolerability of LFSF in participants with intractable MTLE with regards to memory function.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Psychiatric Health (effects of LFS on psychiatric symptoms using standardized measures that are known to be sensitive to changes to surgical treatment of TLE) [ Time Frame: 1 year ]
    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
  • To assess if electrode implantation in the fornix is feasible as is done in patients with Parkinson's Disease. [ Time Frame: 1 year ]
    The DBS leads are routinely interested for patients with Parkinson's disease. Thus, we plan 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
  • Effect on seizure frequency [ Time Frame: 1 year ]
    We expect LFSF to result in seizure reduction based on our preliminary data and a number of studies. For outcome measures, we will use (1) total percentage of seizure frequency change, (2) change in secondarily generalized seizure frequency, (3) change in seizure-free days.


Original Secondary Outcome:

  • Psychiatric Health (effects of LFS on psychiatric symptoms using standardized measures that are known to be sensitive to changes to surgical treatment of TLE) [ Time Frame: 1 year ]
    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
  • To assess if electrode implantation in the fornix is feasible as is done in patients with Parkinson's Disease. [ Time Frame: 1 year ]
    The DBS leads are routinely interested for patients with Parkinson's disease. Thus, we plan 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
  • Effect on seizure frequency [ Time Frame: 1 year ]
    We expect LFSF to result in seizure reduction based on our preliminary data and a number of studies. For outcome measures, we will use (1) total percentage of seizure frequency change, (2) change in secondarily generalized seizure frequency, (3) change in seizure-free days.
  • Quality of Life using OoLIE31 and SF-36 to assess quality of life [ Time Frame: 1 year ]
    We will use the eight domains of the SF-36 (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.


Information By: George Washington University

Dates:
Date Received: February 19, 2015
Date Started: December 2013
Date Completion: January 2019
Last Updated: February 16, 2017
Last Verified: February 2017