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

NCT02383407 | Completed Results DMC

• 1 other identifier: 111239
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesial Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  1 year

• To Assess if Electrode Implantation in the Fornix is Feasible as is Done in Patients With Parkinson's Disease.

  1 year

• Effect on Seizure Frequency

  1 year

Study Arms (2)

Stimulation group 2 Hz

EXPERIMENTAL

Patient will be randomized to a stimulation group of 2 Hz using Medtronic deep brain stimulation device

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

Device: Medtronic Deep Brain Stimulation

Interventions

Medtronic Deep Brain Stimulation DEVICE

Stimulation group 2 Hz; Stimulation group 5 Hz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• 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.

  PMID: 35344808 BACKGROUND

Related Links

• PubMed

Results Point of Contact

• Title: Dr. Mohamad Koubeissi
• Organization: George Washington University

mkoubeissi@mfa.gwu.edu

202-741-2533

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PI

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 9, 2015
• Study Start: December 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Locations

US (1)