Mesial Temporal Lobe EpilepsyMTLE-DBSNCT02383407
Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
A study testing Medtronic Deep Brain Stimulation in people with Mesial Temporal Lobe Epilepsy, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mesial Temporal Lobe Epilepsy
- What is being tested?
- Medtronic Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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:
- Neoplasm with life expectancy < 5 years
- Severe chronic pulmonary disease
- Local, systemic acute or chronic infectious illness
- Life threatening cardiac arrhythmias
- Severe collagen vascular disorder
- Kidney failure or other major organ system failures
Trial locations and contacts
1 site in 1 country.
United States1 site
GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
Read the detailed 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.
- Conditions
- Mesial Temporal Lobe Epilepsy
- Being tested
- Medtronic Deep Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Deep Brain StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Stimulation group 2 Hz | Experimental | Patient will be randomized to a stimulation group of 2 Hz using Medtronic deep brain stimulation device Receives: Device: Medtronic Deep Brain Stimulation |
| Stimulation group 5 Hz | Experimental | Patient will be randomized to a stimulation group of 5 Hz using Medtronic deep brain stimulation device Receives: Device: Medtronic Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startDec 2013
- Primary completionJan 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mesial Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Koubeissi, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383407
- Sponsor's protocol ID
- 111239
- Acronym
- MTLE-DBS
- Status last verified
- Jun 2023
- First submitted
- 19 Feb 2015
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Koubeissi MZ, Joshi S, Eid A, Emami M, Jaafar N, Syed T, Foreman PJ, Sheth A, Amdur R, Bou Nasif M, Puente AN, Aly R, Chen H, Becker A, Gholipour T, Makke Y, Elmashad A, Gagnon L, Durand DM, Gaillard WD, Shields DC. Low-frequency stimulation of a fiber tract in bilateral temporal lobe epilepsy. Epilepsy Behav. 2022 May;130:108667. doi: 10.1016/j.yebeh.2022.108667. Epub 2022 Mar 26.
PubMed 35344808
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
- ClinicalTrials.gov ID
- NCT02383407
- Acronym / sponsor ID
- MTLE-DBS / 111239
- Conditions
- Mesial Temporal Lobe Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation group 2 Hz | Experimental | Device: Medtronic Deep Brain StimulationPatient will be randomized to a stimulation group of 2 Hz using Medtronic deep brain stimulation device |
| Stimulation group 5 Hz | Experimental | Device: Medtronic Deep Brain StimulationPatient will be randomized to a stimulation group of 5 Hz using Medtronic deep brain stimulation device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Deep Brain Stimulation | Device | Stimulation group 2 Hz, Stimulation group 5 Hz |
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. The number of participants listed are those who had a significant changes in RAVLT score.
3 secondary outcomes
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
To Assess if Electrode Implantation in the Fornix is Feasible as is Done in Patients With Parkinson's Disease.
Time frame: 1 year
Effect on Seizure Frequency
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35344808Koubeissi MZ, Joshi S, Eid A, Emami M, Jaafar N, Syed T, Foreman PJ, Sheth A, Amdur R, Bou Nasif M, Puente AN, Aly R, Chen H, Becker A, Gholipour T, Makke Y, Elmashad A, Gagnon L, Durand DM, Gaillard WD, Shields DC. Low-frequency stimulation of a fiber tract in bilateral temporal lobe epilepsy. Epilepsy Behav. 2022 May;130:108667. doi: 10.1016/j.yebeh.2022.108667. Epub 2022 Mar 26.
- PubMedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Deep Brain Stimulation in people with Mesial Temporal Lobe Epilepsy, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Low Frequency Stimulation of the Fornix With Regards to Memory Function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02383407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.