Controlled Randomized Stimulation Versus Resection (CoRaStiR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-01

Study Completion Date

2009-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Implantation intracranial electrode with immediate stimulation

Group Type ACTIVE_COMPARATOR

Implantation of an intracranial electrode

Intervention Type DEVICE

Implantation of an intracranial electrode will be followed.

Implantation intracranial electrode without stimulation

Group Type PLACEBO_COMPARATOR

Implantation of an intracranial electrode

Intervention Type DEVICE

Implantation of an intracranial electrode will be followed.

Resective surgery: amygddohyppocampertomy

Group Type ACTIVE_COMPARATOR

amygddohyppocampertomy

Intervention Type PROCEDURE

Resective surgery

Interventions

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Implantation of an intracranial electrode

Implantation of an intracranial electrode will be followed.

Intervention Type DEVICE

amygddohyppocampertomy

Resective surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No