Controlled Randomized Stimulation Versus Resection (CoRaStiR) - Full Text View

Sponsors and Collaborators:	University Hospital, Ghent Medtronic
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00431457

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

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy 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)

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.
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.

Secondary Outcome Measures:

To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.
Additional Study Measures:
responder rates during 3 month intervals
mean seizure free interval during 3 month intervals
seizure severity and seizure type during 3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Safety Objectives:
Operative and postoperative complications and long-term side effects

Estimated Enrollment:	45
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Sponsors and Collaborators

University Hospital, Ghent

Medtronic

Investigators

Principal Investigator:

Paul Boon, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Paul Boon )
Study ID Numbers:	2007/005
Study First Received:	February 2, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00431457 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Epilepsy
Central Nervous System Diseases
Brain Diseases
Epilepsy, Temporal Lobe

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009