Controlled Randomized Stimulation Versus Resection (CoRaStiR)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Collaborator:
Medtronic
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00431457
First received: February 2, 2007
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epilepsy |
Device: Implantation of an intracranial electrode Procedure: amygddohyppocampertomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- responder rates during 3 month intervals [ Time Frame: 3 months intervals ] [ Designated as safety issue: No ]
- mean seizure free interval during 3 month intervals [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]
- seizure severity and seizure type during 3-month intervals [ Time Frame: 3-month intervals ] [ Designated as safety issue: No ]
- quality of life: changes in QOLIE 89 score at 6 and 12 months [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
- mood assessment: changes in Beck depression scale scores at 6 and 12 month [ Time Frame: at 6 and 12 month ] [ Designated as safety issue: No ]
- Safety Objectives: [ Time Frame: during twelve months after inclusion ] [ Designated as safety issue: No ]
- Operative and postoperative complications and long-term side effects [ Time Frame: during twelve months after inclusion ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Implantation intracranial electrode with immediate stimulation |
Device: Implantation of an intracranial electrode
Implantation of an intracranial electrode will be followed.
|
| Placebo Comparator: Implantation intracranial electrode without stimulation |
Device: Implantation of an intracranial electrode
Implantation of an intracranial electrode will be followed.
|
| Active Comparator: Resective surgery: amygddohyppocampertomy |
Procedure: amygddohyppocampertomy
Resective surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431457
Contacts
| Contact: Kristl Vonck, MD | + 32 9 332.64.88 | kristl.vonck@UGent.be |
Locations
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Kristl Vonck, MD + 32 9 332.64.88 kristl.vonck@UGent.be | |
| Principal Investigator: Kristl Vonck, MD | |
| Germany | |
| UKB Universitätsklinikum Bonn | Recruiting |
| Bonn, Germany | |
| Contact: Michael Malter, MD +49 228 287 15 748 michael.malter@ukb.uni-bonn.de | |
| Principal Investigator: Michael Malter, MD | |
| Universitätsklinikum Freiburg | Recruiting |
| Freiburg, Germany | |
| Contact: Andreas Schulze-Bonhage, PhD +49 761 270 53 66 andreas.schulze-bonhage@uniklinik-freiburg.de | |
| Principal Investigator: Andreas Schulze-Bonhage, PhD | |
Sponsors and Collaborators
University Hospital, Ghent
Medtronic
Investigators
| Principal Investigator: | Paul Boon, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00431457 History of Changes |
| Other Study ID Numbers: | 2007/005 |
| Study First Received: | February 2, 2007 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Temporal Lobe Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial |
ClinicalTrials.gov processed this record on May 16, 2013