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Controlled Randomized Stimulation Versus Resection (CoRaStiR)

NCT00431457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Implantation of an intracranial electrode

Implantation of an intracranial electrode will be followed.

PROCEDURE

amygddohyppocampertomy

Resective surgery

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Paul Boon, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-01
Primary Completion
2009-12-01
Completion
2009-12-01

Countries

  • Belgium
  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00431457 on ClinicalTrials.gov