Controlled Randomized Stimulation Versus Resection (CoRaStiR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014