Controlled Randomized Stimulation Versus Resection (CoRaStiR)

This study is currently recruiting participants.
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
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 April 17, 2014