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

NCT00717431 | Terminated Phase 3 DMC

• 1 other identifier: 20492
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporal Lobe Epilepsy

Keywords

Deep Brain Stimulation; Seizures; Epilepsy

Outcome Measures

Primary Outcomes (1)

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

  Months 1-7

Secondary Outcomes (1)

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

  Months 1-7

Study Arms (2)

Hippocampal Stimulation

EXPERIMENTAL

Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention

Procedure: Hippocampal Electrical Stimulation

Hippocampal Implantation

SHAM COMPARATOR

Hippocampal Implantation (Stimulator is turned OFF)Surgical Intervention

Procedure: Hippocampal Electrical Stimulation

Interventions

Hippocampal Electrical Stimulation PROCEDURE

Surgical Implantation of electrode and stimulator

Hippocampal Implantation; Hippocampal Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• University of Western Ontario, Canada: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator

Study Sites (1)

Foothills Medical Centre, Clinical Neurosciences

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe; Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Wiebe, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

CA (1)