EpilepsyNCT00431457
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
A study testing Implantation of an intracranial electrode and amygddohyppocampertomy in people with Epilepsy, run by University Hospital, Ghent at 3 sites in 2 countries.
Trial summary
Patients will be prospectively randomized to 3 different treatment arms: Treatment group 1: patients who undergo medial temporal lobe resection Treatment group 2: patients who receive immediate hippocampal neurostimulation Treatment group 3: patients who are implanted with an intracranial electrode but in whom… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Implantation of an intracranial electrode and amygddohyppocampertomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2007to 1 Dec 2009
- Phase
- Interventional
- 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
- Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy
- Age above 18 years
- TIQ > 80
- Able to give informed consent
- Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries.
- Able to adequately report seizure frequencies using standard seizure diaries
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- Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure
- Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI
- Women of child-bearing age will be required to use a reliable method of contraception during the study duration
Who cannot join
- Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy
- MR evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas
- Prior resective intracranial surgery
- Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording
- Patients who previously underwent any other type of neurostimulation for treating epilepsy
- Patients who are unable to fill in questionnaires and comply with protocol requirements
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- Progressive neurological or medical conditions
- Medical or psychiatric conditions precluding surgery or compliance
- Patients taking antidepressant medication
- Pregnancy at study onset
- Previous (within the last 3 months), ongoing or planned participation in other treatment study protocols for epilepsy
- Contraindication for intracranial surgery
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
UKB Universitätsklinikum Bonn
Bonn
Universitätsklinikum Freiburg
Freiburg im Breisgau
About this study
Official title: Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Patients will be prospectively randomized to 3 different treatment arms:
- Treatment group 1: patients who undergo medial temporal lobe resection
- Treatment group 2: patients who receive immediate hippocampal neurostimulation
- Treatment group 3: patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months.
Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery.
Study visits will occur every 3 months.
- Conditions
- Epilepsy
- Being tested
- Implantation of an intracranial electrode, amygddohyppocampertomy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an intracranial electrodeDevice
Implantation of an intracranial electrode will be followed.
amygddohyppocampertomyProcedure or surgery
Resective surgery
| Study group | Role | What they receive |
|---|---|---|
| Implantation intracranial electrode with immediate stimulation | Active comparator | Not described Receives: Device: Implantation of an intracranial electrode |
| Implantation intracranial electrode without stimulation | Placebo comparator | Not described Receives: Device: Implantation of an intracranial electrode |
| Resective surgery: amygddohyppocampertomy | Active comparator | Not described Receives: Procedure: amygddohyppocampertomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up.
Measured: 6 months
To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up.
Measured: at 6 and 12 months of follow-up
Secondary outcomes (8)
To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.
Measured: at 12 months of follow-up
responder rates during 3 month intervals
Measured: 3 months intervals
mean seizure free interval during 3 month intervals
Measured: 3 month intervals
seizure severity and seizure type during 3-month intervals
Measured: 3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
Measured: at 6 and 12 months
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Measured: at 6 and 12 month
Safety Objectives:
Measured: during twelve months after inclusion
Operative and postoperative complications and long-term side effects
Measured: during twelve months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study start1 Jun 2007
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Paul Boon, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431457
- Sponsor's protocol ID
- 2007/005
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2007
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.
PubMed 24777136
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Stimulation Versus Resection (CoRaStiR)
- ClinicalTrials.gov ID
- NCT00431457
- Acronym / sponsor ID
- 2007/005
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 5 Feb 2007 (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.
Patients will be prospectively randomized to 3 different treatment arms:
- Treatment group 1: patients who undergo medial temporal lobe resection
- Treatment group 2: patients who receive immediate hippocampal neurostimulation
- Treatment group 3: patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months.
Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery.
Study visits will occur every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implantation intracranial electrode with immediate stimulation | Active comparator | Device: Implantation of an intracranial electrode |
| Implantation intracranial electrode without stimulation | Placebo comparator | Device: Implantation of an intracranial electrode |
| Resective surgery: amygddohyppocampertomy | Active comparator | Procedure: amygddohyppocampertomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy
- Age above 18 years
- TIQ > 80
- Able to give informed consent
- Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries.
Key exclusion criteria (12 listed)
- Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy
- MR evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas
- Prior resective intracranial surgery
- Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording
- Patients who previously underwent any other type of neurostimulation for treating epilepsy
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 |
|---|---|---|
| Implantation of an intracranial electrodeImplantation of an intracranial electrode will be followed. | Device | Implantation intracranial electrode with immediate stimulation, Implantation intracranial electrode without stimulation |
| amygddohyppocampertomyResective surgery | Procedure or surgery | Resective surgery: amygddohyppocampertomy |
Primary outcome
To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up.
Time frame: 6 months
To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up.
Time frame: at 6 and 12 months of follow-up
8 secondary outcomes
To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.
Time frame: at 12 months of follow-up
responder rates during 3 month intervals
Time frame: 3 months intervals
mean seizure free interval during 3 month intervals
Time frame: 3 month intervals
seizure severity and seizure type during 3-month intervals
Time frame: 3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
Time frame: at 6 and 12 months
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Time frame: at 6 and 12 month
Safety Objectives:
Time frame: during twelve months after inclusion
Operative and postoperative complications and long-term side effects
Time frame: during twelve months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 24777136Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Paul Boon, MD, PhD principal investigator
University Hospital, Ghent
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an intracranial electrode and amygddohyppocampertomy in people with Epilepsy, run by University Hospital, Ghent at 3 sites in 2 countries.
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 12 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: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431457, which also lists 1 linked publication.
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 25 Jan 2023.