Controlled Randomized Stimulation Versus Resection (CoRaStiR)

Epilepsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431457
• Other study ID #: 2007/005
• Status: Completed
• Phase: N/A
• Start date: June 1, 2007
• Est. completion date: December 1, 2009

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 1, 2009
• Est. primary completion date: December 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Implantation of an intracranial electrode
Implantation of an intracranial electrode will be followed.

Procedure:
• amygddohyppocampertomy
Resective surgery

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Germany	UKB Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Freiburg	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medtronic

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

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

External Links

•   Website of the University Hospital Ghent