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| Sponsor: | University of Calgary |
|---|---|
| Collaborators: |
University of Western Ontario, Canada University of Toronto Dalhousie University University of Alberta |
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00717431 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Temporal Lobe Epilepsy |
Procedure: Hippocampal Electrical Stimulation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Medical vs Electrical Therapy for Temporal Lobe Epilepsy |
| Estimated Enrollment: | 57 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hippocampal Stimulation
Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention
|
Procedure: Hippocampal Electrical Stimulation
Surgical Implantation of electrode and stimulator
|
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Sham Comparator: Hippocampal Implantation
Hippocampal Implantation (Stimulator is turned OFF)Surgical Intervention
|
Procedure: Hippocampal Electrical Stimulation
Surgical Implantation of electrode and stimulator
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Supriya Save, PhD | 403-944-4556 | supriya.save@albertahealthservices.ca |
| Contact: Lisa Anderson, MSc | 403-210-6372 | lisamaria.anderson@albertahealthservices.ca |
| Canada, Alberta | |
| Foothills Medical Centre, Clinical Neurosciences | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Supriya Save, PhD 403-944-4556 supriya.save@albertahealthservices.ca | |
| Contact: Christina Ma, MSc 403-210-6372 chrma@ucalgary.ca | |
| Principal Investigator: Samuel Wiebe, MD | |
| Principal Investigator: | Samuel Wiebe, MD | University of Calgary |
More Information
| Responsible Party: | Samuel Wiebe MD, MSc, FRCPC, Foothills Medical Centre, Dept. Clinical Neurosciences |
| ClinicalTrials.gov Identifier: | NCT00717431 History of Changes |
| Other Study ID Numbers: | 20492 |
| Study First Received: | July 15, 2008 |
| Last Updated: | December 21, 2010 |
| Health Authority: | Canada: Health Canada |
|
Deep Brain Stimulation Seizures Epilepsy |
|
Epilepsy Epilepsy, Temporal Lobe Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial |