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

NCT ID: NCT00717431

Last Updated: 2012-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

Brief 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.

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?

Conditions

Temporal Lobe Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hippocampal Stimulation

Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention

Group Type: EXPERIMENTAL

Hippocampal Electrical Stimulation

Intervention Type: PROCEDURE

Surgical Implantation of electrode and stimulator

Hippocampal Implantation

Hippocampal Implantation (Stimulator is turned OFF)Surgical Intervention

Group Type: SHAM_COMPARATOR

Hippocampal Electrical Stimulation

Intervention Type: PROCEDURE

Surgical Implantation of electrode and stimulator

Interventions

Hippocampal Electrical Stimulation

Surgical Implantation of electrode and stimulator

Intervention Type: PROCEDURE

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sam Wiebe

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Wiebe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre, Clinical Neurosciences

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

20492

Identifier Type: -

Identifier Source: org_study_id