Primary objective of this clinical investigation is to evaluate superiority of the signal quality of SOFT ECoG flexible high-density electrode grids compared to regular high-density electrode grids, routinely used at the UMC Utrecht. The signal…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The average background SNR of pre-resection recording electrodes of test device
(TD) compared to control device (CD)
Secondary outcome
Secundary endpoints, for TD in comparison to the CD are:
- low electrode deficiency rate (% of electrodes recording low quality signal
(e.g., visible noise or no signal in regular settings) in the pre-resection and
post-resection recordings
- improved signal quality for epileptic biomarker identification (e.g., number
of spikes/HFOs per minute in pre-resection recording, averaged SNR of these
events)
- low background SNR in the post-resection recording
- safe (surgical complications via SAE/SADE monitoring)
- acceptable usability profile (system usability scales, device deficiencies)
Background summary
The development of flexible electrodes aims to provide high quality recording
of intraoperative electrocorticography (ioECoG). During epilepsy surgery, the
use of high density, flexible electrodes that can provide high quality
recordings may improve diagnostic efficacy by better defining the epileptogenic
cortex and ultimately improving the epilepsy surgery outcomes. The objective of
this clinical investigation is to evaluate the safety of clinical use of SOFT
ECoG flexible electrode grids (test device; TD), manufactured by Neurosoft
Bioelectronics in epilepsy surgery patients and to assess the device
performance in signal quality, when compared to standard of care CE-marked
similar device (control device; CD).
Study objective
Primary objective of this clinical investigation is to evaluate superiority of
the signal quality of SOFT ECoG flexible high-density electrode grids compared
to regular high-density electrode grids, routinely used at the UMC Utrecht. The
signal quality is determined by the background signal-to-noise ratio (SNR) of
pre-resection recordings, for the spike (0-80Hz), ripple (80-250Hz) and fast
ripple band (250-500Hz).. Secondary objectives are: number of epileptiform
events (e.g., interictal epileptiform discharges, ripples and fast ripples),
SNR of these events, SNR of the background signal post-resection recordings,
electrode deficiency rate (%), and usability. All adverse events and device
deficiencies will be recorded and analysed for both the TD and CD
Study design
Prospective interventional mono-centric pilot study.
Intervention
In addition to standard clinical protocol, subjects will undergo >= 2 additional
intracranial recordings pre- and post-resection with the SOFT ECoG flexible
high density electrode grid (TD) next to the standard high density electrode
grid during epilepsy surgery. All procedures will be conducted according to
standard clinical practice. Any medical decision making will be done using the
standard of care CE-marked device (CD). The investigational, non-CE marked
device is not used for clinical decision making.
Study burden and risks
The most important investigational device or procedure related risk, associated
with subjects* participation in this clinical investigation is a prolonged
overall surgical time (by approximately 20-30 minutes) (2x5 minutes extra for
ECoG recordings with investigational device). Lengthening of the neurosurgical
procedure poses an increased risk of surgical complications such as infection
or bleeding to study subjects. Those complications are however, very rare in
clinical practice (<1/1000) and the overall risk is deemed acceptable,
considering non-significantly prolonged procedural time.
The study participants will not benefit directly from the participation in this
clinical investigation. The obtained information will be useful for future
surgeries in general. However, in case of unsuccessful surgery the additional
recordings made with the SOFT ECoG - only when non-inferiority is established
in this pilot - may contribute to the individual patient future clinical
trajectory.
Chemin des Cornillons 94
Chambésy CH-1292
CH
Chemin des Cornillons 94
Chambésy CH-1292
CH
Listed location countries
Age
Inclusion criteria
1.Age >=18 years at the time of enrolment
2.Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is
considered a candidate for intra-operative high-density grid recordings (incl.
patients who underwent sEEG preceding resective surgery)
3.Provided informed consent for study participation by the subject
Exclusion criteria
- Prior brain surgery (excl. SEEG)
- Occipital lesion
- Surgeries involving a primary mesial temporal lesion, a disconnection, or
hemispherectomy.
- Planned awake surgery and/or functional recordings
- Use of anticoagulants that cannot be discontinued during the perioperative
period, or a factor XIII deficiency or any other haematological disease
-Active participation in another investigational device study
- Any other condition that in the opinion of the investigator may adversely
affect the safety of the subject or would limit the subject*s ability to
complete the study.
- Insufficient understanding of Dutch language.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06205160 |
| CCMO | NL85917.000.23 |