Controlled Randomized Stimulation Versus Resection (CoRaStiR)

January 24, 2023 updated by: University Hospital, Ghent

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
  • Germany
      • Bonn, Germany
        • UKB Universitätsklinikum BONN
      • Freiburg, Germany
        • Universitätsklinikum Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months
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
at 6 and 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 12 months of follow-up
responder rates during 3 month intervals
Time Frame: 3 months intervals
3 months intervals
mean seizure free interval during 3 month intervals
Time Frame: 3 month intervals
3 month intervals
seizure severity and seizure type during 3-month intervals
Time Frame: 3-month intervals
3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
Time Frame: at 6 and 12 months
at 6 and 12 months
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Time Frame: at 6 and 12 month
at 6 and 12 month
Safety Objectives:
Time Frame: during twelve months after inclusion
during twelve months after inclusion
Operative and postoperative complications and long-term side effects
Time Frame: during twelve months after inclusion
during twelve months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Medtronic

Investigators

  • Principal Investigator: Paul Boon, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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