Temporal Lobe EpilepsyPhase 3METTLENCT00717431
A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy
A Phase 3 study testing Hippocampal Electrical Stimulation in people with Temporal Lobe Epilepsy, run by University of Calgary at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- Hippocampal Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical vs Electrical Therapy for Temporal Lobe Epilepsy
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.
Read the 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:
- 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?
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- Hippocampal Electrical Stimulation
- Keywords
- Deep Brain Stimulation, Seizures, Epilepsy
- Medical subject headings
- Epilepsy, Temporal Lobe, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hippocampal Electrical StimulationProcedure or surgery
Surgical Implantation of electrode and stimulator
| Study group | Role | What they receive |
|---|---|---|
| Hippocampal Stimulation | Experimental | Hippocampal Stimulation (Stimulator is turned ON) Surgical Intervention Receives: Procedure: Hippocampal Electrical Stimulation |
| Hippocampal Implantation | Sham comparator | Hippocampal Implantation (Stimulator is turned OFF)Surgical Intervention Receives: Procedure: Hippocampal Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complex partial seizures (with or without secondary generalization) per person-month over 6 months of follow-up.
Measured: Months 1-7
Secondary outcomes (1)
Cognitive function: Change in mean scores from baseline to end of study.
Measured: Months 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: insufficient enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Toronto, Dalhousie University, University of Alberta
- Responsible party
- Principal investigator, Dr. Sam Wiebe, University of Calgary
- Investigators
- Samuel Wiebe, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717431
- Sponsor's protocol ID
- 20492
- Acronym
- METTLE
- Status last verified
- Mar 2012
- First submitted
- 15 Jul 2008
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical vs Electrical Therapy for Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT00717431
- Acronym / sponsor ID
- METTLE / 20492
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- Deep Brain Stimulation, Seizures, Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrolment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, University of Toronto, Dalhousie University, University of Alberta
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippocampal Stimulation | Experimental | Procedure: Hippocampal Electrical StimulationHippocampal Stimulation (Stimulator is turned ON) Surgical Intervention |
| Hippocampal Implantation | Sham comparator | Procedure: Hippocampal Electrical StimulationHippocampal Implantation (Stimulator is turned OFF)Surgical Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hippocampal Electrical StimulationSurgical Implantation of electrode and stimulator | Procedure or surgery | Hippocampal Implantation, Hippocampal Stimulation |
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
1 secondary outcome
Cognitive function: Change in mean scores from baseline to end of study.
Time frame: Months 1-7
Results and safety
The study was stopped early (reason given: insufficient enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Wiebe, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hippocampal Electrical Stimulation in people with Temporal Lobe Epilepsy, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complex partial seizures (with or without secondary generalization) per person-month over 6 months of follow-up. (time frame: Months 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.