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Intra-operative detection and localisation of high frequency oscillations in the ECoG to guide epilepsy surgery

Intra-operative detection and localisation of high frequency oscillations in the ECoG to guide epilepsy surgery - The HFO study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45156
Enrollment
78
Registered
2014-03-18
Start date
2014-11-06
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

hersenen, focale epilepsie refractory focal epilepsy

Interventions

Eligible patients will be randomised, after informed consent is signed, into group 1 (HFOs) in whom a resection of epileptogenic tissue is guided by HFOs in the aECoG (new), or into group 2 (spikes)

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients of all ages with: - Focal epilepsy that are planned for neurosurgery with aECoG, with the goal of tailoring the resection. -Command of Dutch language of the patient/parents/legal representatives and capability of completing the questionnaires (by email or phone).

Exclusion criteria

Exclusion criteria: - Patients who underwent chronic ECoG monitoring preceding epilepsy surgery. - Patients with an occipital focus undergoing aECoG. - Patients with tailored tumor surgery with expected progressive course of disease (e.g. expected tumor growth, planned radiotherapy after surgery).*

Design outcomes

Primary

MeasureTime frame
Outcome after epilepsy surgery after 1 year of follow-up dichotomized in total seizure freedom (Engel classification Ia&b) vs. seizure recurrence (Engel classification Ic-IV).

Secondary

MeasureTime frame
Secundary study parameters are pre- vs post opertive differences in volume of brain tissue removed, neurological deficits, cognitive functioning, duration of surgery and aECoG recording and health related quality of life (QoL).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)