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TerminatedNCT00717431METTLEUpdated Apr 2, 2012

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

A Phase 3 interventional study of Hippocampal Electrical Stimulation in Temporal Lobe Epilepsy, sponsored by University of Calgary. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-02.

Sponsored by University of Calgary · Phase 3, Interventional, and Treatment

Why this study was terminated
insufficient enrolment
Phase
Phase 3
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

This is a multicentre, parallel-group, double blind randomized controlled trial involving patients with MTLE who may be candidates for resective surgery or whose memory function precludes resective surgery. Eligible patients will be randomized in a 2:1 ratio into hippocampal electrode implantation with stimulation (HS), or hippocampal electrode implantation without stimulation (HI). Patients will be followed for seven months after randomization. One month will be devoted to adjustment of interventions, and 6 months to follow-up and outcome assessment. At the end of seven months, all patients will be offered the option of HS, electrode removal, surgical therapy or medical therapy, based on best evidence and patient preference.

Primary Question: In patients with MTLE, over a 6-month period:

Is continuous HS plus medical therapy (MT) more efficacious than hippocampal implantation (HI) plus MT in reducing seizure frequency?

Secondary Questions: In patients with MTLE, over a 6-month period:

  1. Is HS safe?
  2. What is the effect of HS on cognition, mood, and quality of life?
  3. What is the effect of HS on psychiatric morbidity?
  4. Is the efficacy of HS associated with the presence, location and amount of interictal hippocampal spikes on depth electrode recordings?
02

Conditions studied

  • Temporal Lobe Epilepsy

Keywords

  • Deep Brain Stimulation
  • Seizures
  • Epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 negative pregnancy test and adequate contraception methods.
  • Ongoing or planned participation in other studies of new epilepsy therapies.
  • Contraindication for stereotactic surgery, e.g. bleeding diathesis, anticoagulants, treatment with valproate at the time of surgery (risk of bleeding).
  • Any condition that would make participation in the trial detrimental to the patient's health.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Hippocampal Stimulation

    Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention

    Procedure: Hippocampal Electrical Stimulation

  • Sham comparator
    Hippocampal Implantation

    Hippocampal Implantation (Stimulator is turned OFF)Surgical Intervention

    Procedure: Hippocampal Electrical Stimulation

Interventions

  • ProcedureHippocampal Electrical Stimulation

    Surgical Implantation of electrode and stimulator

06

What researchers measure

Primary outcomes

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

    Time frame: Months 1-7

Secondary outcomes

  1. Cognitive function: Change in mean scores from baseline to end of study.

    Time frame: Months 1-7

07

Study locations

1 site
  • Foothills Medical Centre, Clinical Neurosciences
    Calgary, Alberta, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00717431
Lead sponsor
University of Calgary
Collaborators
University of Western Ontario, Canada, University of Toronto, Dalhousie University, University of Alberta
Responsible party
Dr. Sam Wiebe (Professor, University of Calgary) — Principal investigator
First posted
Jul 17, 2008
Start date
Jan 2008
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Apr 2, 2012

Study contacts

Samuel Wiebe, MD
principal investigator · University of Calgary

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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