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A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy

NCT00717431 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-04-02

No results posted yet for this study

Summary

The primary goal is to determine whether hippocampal electrical stimulation (HS) is safe and more effective than simply implanting an electrode in the hippocampus without electrical stimulation (HI), in patients with mesial temporal lobe epilepsy (MTLE). This will be assessed by the rate of complex partial seizures per person-month over 6 months of follow-up in HS vs. HI. There are two treatment arms: 1) Hippocampal Electrode Implantation with Stimulation (HS). 2) Hippocampal Electrode Implantation without stimulation (HI). The investigators expect to demonstrate that HS is safe and superior to HI in controlling seizures in patients with MTLE.

Conditions

  • Temporal Lobe Epilepsy

Interventions

PROCEDURE

Hippocampal Electrical Stimulation

Surgical Implantation of electrode and stimulator

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Samuel Wiebe, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717431 on ClinicalTrials.gov