NCT02320136

Brief Summary

The investigators want to characterize high-frequency oscillations (HFOs) in intracranial recordings, which may occur as markers of epileptogenic tissue and also under physiological stimulation. The investigators want to show that recording of high-frequency oscillations (HFOs) is feasible in our project population both intraoperatively and during presurgical physiological conditions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

10.5 years

First QC Date

December 15, 2014

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • HFO (high-frequency oscillations) occurrence

    1 week

Study Arms (3)

epilepsy

epilepsy patients

Behavioral: cognitive testing

tumor with epilepsy

tumor patients with epileptic seizures

Behavioral: cognitive testing

tumor without epilepsy

tumor patients without epileptic seizures

Behavioral: cognitive testing

Interventions

patients perform simple tasks like watching a video or memorizing items

epilepsytumor with epilepsytumor without epilepsy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Patients with epilepsy where a surgical resection is considered. 2. Patients where a tumor will be resected that has caused preoperative seizures. 3. Patients where a tumor will be resected that has not caused preoperative seizures.

You may qualify if:

  • Patients intend to be treated at the Klinik für Neurochirurgie
  • Patients fall into one of the patient groups: (1) Patients with symptomatic epilepsy with focal and/or secondary generalized seizures resistant to medication where a neurosurgical resection is considered as an intervention of epilepsy surgery. (2)Patients where a tumor is planned to be resected that has caused preoperative seizures. (3) Patients where a tumor is planned to be resected that has not caused preoperative seizures.
  • Male and Female subjects 18 years to 99 years of age
  • Written informed consent after participants' information

You may not qualify if:

  • contraindications on ethical grounds
  • known or suspected non-compliance, drug or alcohol abuse,
  • enrolment into a clinical trial within last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EpilepsyNeoplasms

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Johannes Sarnthein, Prof Dr

    Universitätsspital Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 19, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

December 1, 2023

Record last verified: 2023-11