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Completed

NCT Number: NCT00431457

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of an intracranial electrode

Device

Implantation of an intracranial electrode will be followed.

amygddohyppocampertomy

Procedure

Resective surgery

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. responder rates during 3 month intervals

    Time frame: 3 months intervals

  3. mean seizure free interval during 3 month intervals

    Time frame: 3 month intervals

  4. seizure severity and seizure type during 3-month intervals

    Time frame: 3-month intervals

  5. quality of life: changes in QOLIE 89 score at 6 and 12 months

    Time frame: at 6 and 12 months

  6. mood assessment: changes in Beck depression scale scores at 6 and 12 month

    Time frame: at 6 and 12 month

  7. Safety Objectives:

    Time frame: during twelve months after inclusion

  8. Operative and postoperative complications and long-term side effects

    Time frame: during twelve months after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2007
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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