Clinical Trial: A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Medical vs Electrical Therapy for Temporal Lobe Epilepsy
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 Summary:
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:
- Is HS safe?
- What is the effect of HS on cognition, mood, and quality of life?
- What is the effect of HS on psychiatric morbidity?
- Is the efficacy of HS associated with the presence, location and amount of interictal hippocampal spikes on depth electrode recordings?
Sponsor: University of Calgary
Current Primary Outcome: Rate of complex partial seizures (with or without secondary generalization) per person-month over 6 months of follow-up. [ Time Frame: Months 1-7 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Cognitive function: Change in mean scores from baseline to end of study. [ Time Frame: Months 1-7 ]
Original Secondary Outcome: Same as current
Information By: University of Calgary
Dates:
Date Received: July 15, 2008
Date Started: January 2008
Date Completion:
Last Updated: March 28, 2012
Last Verified: March 2012
