Utility of Pt-Au intracranial electrode

JRCT ID: jRCTs052180099

Registered date:06/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Epilepsy, Brain tumor
• Date of first enrollment: 09/05/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): none

Outcome(s)

• Primary Outcome: Using intraoperative photographs, it is possible to confirm the positional relationship between the electrode and the cerebral cortex before and after MRI imaging from information such as cerebral groove, and it is possible to evaluate the displacement of the electrode by MRI imaging. We also evaluate whether the structure of the brain cortex can be confirmed even under electrode indwelling by using 3D reconstructed image of MRI.
• Secondary Outcome: In order to confirm the safety of 3 Tesla MRI imaging under indwelling of electrodes, it was confirmed whether there was a problem on the electrode adhesion surface visually after removal of the electrode, in addition to confirming the safety of pathology Also submit it to the examination to check whether there is a problem such as thermal denaturation or contusion injury caused by MRI imaging under electrode indwelling.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Over 20 years old
2. Understand the explanation, you can confirm your consent
3. It is judged that lesions are in the sensory motor cortex, visual cortex, auditory cortex, language field, association cortex and electrophysiological mapping / monitoring during removal surgery
4. Due to the nature of the lesion, it is necessary to evaluate by MRI imaging during the surgical operation (when imaging under indwelling electrodes during operation)

Exclude criteria

1. uncontrolled respiratory and cardiovascular diseases
2. easily infectious
3. Cardiac pacemaker
4. metals in the body that can not be confirmed as being nonmagnetic

Related Information

• Primary Sponsor: Kikuchi Takayuki
• Secondary Sponsor: Yamao Yukihiro