Controlled Randomized Stimulation Versus Resection (CoRaStiR)
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)
1 other identifier
interventional
12
2 countries
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2007
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 5, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 25, 2023
January 1, 2023
2.5 years
February 2, 2007
January 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
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.
at 12 months of follow-up
responder rates during 3 month intervals
3 months intervals
mean seizure free interval during 3 month intervals
3 month intervals
seizure severity and seizure type during 3-month intervals
3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
at 6 and 12 months
- +3 more secondary outcomes
Study Arms (3)
Implantation intracranial electrode with immediate stimulation
ACTIVE COMPARATORImplantation intracranial electrode without stimulation
PLACEBO COMPARATORResective surgery: amygddohyppocampertomy
ACTIVE COMPARATORInterventions
Implantation of an intracranial electrode will be followed.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Medtroniccollaborator
Study Sites (3)
University Hospital Ghent
Ghent, 9000, Belgium
UKB Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Related Publications (1)
Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.
PMID: 24777136DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Boon, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 5, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 25, 2023
Record last verified: 2023-01