TerminatedPhase 3

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

Stopped: insufficient enrolment

Canada8 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral or Bilateral Mesial Temporal lobe Epilepsy. * Age ≥ 18 years. * Global IQ ≥70. * Failure of ≥ 2 AEDs approved for treatment of partial seizures, used alone or in combination at recommended dosages. * Average ≥ 3 seizure-days per month in prior 6 months during which disabling seizures occurred. Disabling seizures are defined as complex partial seizures with or without secondary generalization, or as simple partial seizures that are noticeable by others or interfere with function. * Ability to complete self-administered questionnaires. * Availability of reliable collateral historian or witness. * Patient preference for non-resective surgery, or not a candidate for mesial temporal resection. * Give written informed consent. Exclusion Criteria: * Extratemporal or multifocal epilepsy. * MRI evidence of potentially epileptogenic lesions outside the mesial temporal region. * Lesions precluding electrode implantation (eg, vascular malformations, vascular tumors). * Severe hippocampal sclerosis that in the surgeon's opinion precludes accurate electrode placement. * Brain lesions that demand prompt surgical therapy (eg, malignant tumors, vascular malformations). * Progressive neurological disorders (eg, malignant tumor, dementia, degenerative disorders). * Medical or psychiatric conditions precluding surgery or interfering with adherence to treatment and follow-up. * Planned pregnancy during the study. Women of child-bearing age will require a negati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of complex partial seizures (with or without secondary generalization) per person-month over 6 months of follow-up.

Timeframe: Months 1-7

Trial details

NCT IDNCT00717431

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Temporal Lobe Epilepsy trials