High-Density Intraoperative ECoG-A Pilot Study

Completed

• Conditions: icm basaal hersenfunctie onderzoek; NA; 10042258

• Registration Number: NL-OMON55585
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-10-02
• Study Completion: 2023-04-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

- age 18 years and higher
- a clinical indication for resection of a tumor or other lesion (e.g. focus of
epileptic seizures), with or without routine low-density ECoG recordings
- a clinical indication for awake (primary objective 1+ 2) or sedated surgery
(during the initial, development phase of primary objective 1 + primary
objective 2)

Exclusion Criteria

- indication for longer than average (225 min) duration of the procedure
(estimation by the neurosurgeon) (primary objective 1)
- the neurosurgeon decides that a certain patient is not eligible to
participate in the study (e.g. for medical or surgical reasons)
- planned trepanation too far away for grid placement on a target location
(evaluation by the neurosurgeon and researcher combined) (primary objective 1)
- reported function loss in the domain of motor action and visual perception
that may interfere with proper task execution (primary objective 1)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective 1 - Recording functional HD-ECoG data<br /><br>Principal parameter is the electrophysiological signal as measured from healthy<br /><br>tissue with the high-density electrode grid and dedicated HD-ECoG recording<br /><br>equipment. Key endpoint is the correlation between the brain activity recorded<br /><br>as such and an imposed task (R-squared value) and the comparison of the<br /><br>R-squared value with those obtained at the IEMU.<br /><br><br /><br>Primary objective 2 - Recording HD-ECoG data from epileptogenic tissue<br /><br>Principal parameter is the electrophysiological signal as measured from<br /><br>epileptogenic tissue with the high-density electrode grid and dedicated HD-ECoG<br /><br>recording equipment in comparison to the routine low-density ECoG recording.<br /><br>Key endpoint is whether epileptiform activity is recorded with the same<br /><br>intensity, recognizability and extent. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>