High-Density Intraoperative ECoG-A Pilot Study

High-Density Intraoperative ECoG-A Pilot Study - High-Density Intraoperative ECoG

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55585

Enrollment

Registered

2015-03-10

Start date

2016-09-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

icm basaal hersenfunctie onderzoek NA

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results