Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Calgary University of Western Ontario, Canada University of Toronto Dalhousie University University of Alberta |
---|---|
Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00717431 |
Our 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), or treating with medical therapy alone (MT), 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, and in HS-HI combined vs. MT. There are three treatment arms: 1) Hippocampal Electrode Implantation with Stimulation (HS). 2) Hippocampal Electrode Implantation without stimulation (HI). 3) Optimum Medical Therapy (MT) alone. We expect to demonstrate that HS is safe and superior to HI and MT in controlling seizures in patients with MTLE.
Condition | Intervention | Phase |
---|---|---|
Temporal Lobe Epilepsy |
Procedure: Hippocampal Electrical Stimulation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial of Hippocampal Stimulation for Temporal Lobe Epilepsy |
Estimated Enrollment: | 90 |
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 |
---|---|
2: Experimental
Hippocampal Implantation (Stimulator is OFF)
|
Procedure: Hippocampal Electrical Stimulation
Surgical Implantation of electrode and stimulator
|
3: Experimental
Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention
|
Procedure: Hippocampal Electrical Stimulation
Surgical Implantation of electrode and stimulator
|
1. Medical Therapy: No Intervention
These patients continue with their anti-epileptic medication only.
|
This is a multicentre, parallel-group, three-arm, 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 1:1:1 ratio into medical therapy only (MT), 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. Our study design and analysis allows for two co-primary hypotheses. Thus: In patients with MTLE, over a 6-month period, a) Is continuous HS plus medical therapy (MT) more efficacious than hippocampal implantation (HI) plus MT in reducing seizure frequency? and b) Is there a difference between any form of hippocampal intervention (HS or HI) and medical MT alone in reducing seizure frequency?
Secondary Questions: In patients with MTLE, over a 6-month period:
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kim Ford | 403-944-4556 | kim.ford@calgaryhealthregion.ca |
Contact: Lisa Anderson, MSc | 403-210-6372 | lisamaria.anderson@calgaryhealthregion.ca |
Canada, Alberta | |
Foothills Medical Centre, Clinical Neurosciences | Recruiting |
Calgary, Alberta, Canada | |
Contact: Kim Ford 403-944-4556 kim.ford@calgaryhealthregion.ca | |
Contact: Lisa Anderson, MSc 403-210-6372 lisamaria.anderson@calgaryhealthregion.ca | |
Principal Investigator: Samuel Wiebe, MD |
Principal Investigator: | Samuel Wiebe, MD | University of Calgary |
Responsible Party: | Foothills Medical Centre, Dept. Clinical Neurosciences ( Samuel Wiebe MD, MSc, FRCPC ) |
Study ID Numbers: | 20492 |
Study First Received: | July 15, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00717431 History of Changes |
Health Authority: | Canada: Health Canada |
Deep Brain Stimulation Seizures Epilepsy |
Epilepsies, Partial Epilepsy Seizures |
Central Nervous System Diseases Brain Diseases Epilepsy, Temporal Lobe |
Epilepsies, Partial Epilepsy Nervous System Diseases |
Central Nervous System Diseases Brain Diseases Epilepsy, Temporal Lobe |