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Controlled Randomized Stimulation Versus Resection (CoRaStiR)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of an intracranial electrode
amygddohyppocampertomy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent
  • UKB Universitätsklinikum Bonn
  • Universitätsklinikum Freiburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Implantation intracranial electrode with immediate stimulation

Implantation intracranial electrode without stimulation

Resective surgery: amygddohyppocampertomy

Arm Description

Outcomes

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.
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

Full Information

First Posted
February 2, 2007
Last Updated
January 24, 2023
Sponsor
University Hospital, Ghent
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00431457
Brief Title
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2007 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implantation intracranial electrode with immediate stimulation
Arm Type
Active Comparator
Arm Title
Implantation intracranial electrode without stimulation
Arm Type
Placebo Comparator
Arm Title
Resective surgery: amygddohyppocampertomy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Implantation of an intracranial electrode
Intervention Description
Implantation of an intracranial electrode will be followed.
Intervention Type
Procedure
Intervention Name(s)
amygddohyppocampertomy
Intervention Description
Resective surgery
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
responder rates during 3 month intervals
Time Frame
3 months intervals
Title
mean seizure free interval during 3 month intervals
Time Frame
3 month intervals
Title
seizure severity and seizure type during 3-month intervals
Time Frame
3-month intervals
Title
quality of life: changes in QOLIE 89 score at 6 and 12 months
Time Frame
at 6 and 12 months
Title
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Time Frame
at 6 and 12 month
Title
Safety Objectives:
Time Frame
during twelve months after inclusion
Title
Operative and postoperative complications and long-term side effects
Time Frame
during twelve months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Boon, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UKB Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24777136
Citation
Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

Controlled Randomized Stimulation Versus Resection (CoRaStiR)

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