Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE) (MTLE-DBS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)|
- Safety and tolerability of low frequency stimulation of the fornix with regards to memory function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The primary outcome is safety and tolerability of LFSF in participants with intractable MTLE with regards to memory function.
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: Stimulation group 1 Hz
Patient will be randomized to a stimulation group of 1 Hz using Medtronic deep brain stimulation device
|Device: Medtronic Deep Brain Stimulation|
Experimental: Stimulation group 5 Hz
Patient will be randomized to a stimulation group of 5 Hz using Medtronic deep brain stimulation device
|Device: Medtronic Deep Brain Stimulation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02383407
|Contact: Mohamad Z. Koubeissi, MDemail@example.com|
|United States, District of Columbia|
|GW Medical Faculty Associates||Recruiting|
|Washington, District of Columbia, United States, 20037|
|Contact: Mohamad Z Koubeissi, MD 202-741-2533 firstname.lastname@example.org|
|Contact: Radwa Aly 202-677-6210 email@example.com|
|United States, Pennsylvania|
|Jefferson Comprehensive Epilepsy Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Michael Sperling, MD 215-955-1222|