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Deep Brain Stimulation

Stimulation group 5 Hz for Mesial Temporal Lobe Epilepsy (MTLE-DBS Trial)

N/A
Waitlist Available
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

MTLE-DBS 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. Secondary aims include evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.

Eligible Conditions
  • Mesial Temporal Lobe Epilepsy

MTLE-DBS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of Low Frequency Stimulation of the Fornix With Regards to Memory Function
Secondary outcome measures
Effect on Seizure Frequency
Psychiatric Health (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.

MTLE-DBS Trial Design

2Treatment groups
Experimental Treatment
Group I: Stimulation group 5 HzExperimental Treatment1 Intervention
Patient will be randomized to a stimulation group of 5 Hz using Medtronic deep brain stimulation device
Group II: Stimulation group 2 HzExperimental Treatment1 Intervention
Patient will be randomized to a stimulation group of 2 Hz using Medtronic deep brain stimulation device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic Deep Brain Stimulation
2013
N/A
~10

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,768 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
Mohamad Koubeissi 2013. "Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02383407.
~1 spots leftby Apr 2025
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