EpilepsyHFONCT02320136
Recording High Frequency Oscillations in Patients With Tumors and Epilepsy
An observational study of Epilepsy and Tumor, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- cognitive testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- contraindications on ethical grounds
- known or suspected non-compliance, drug or alcohol abuse,
- enrolment into a clinical trial within last 4 weeks
About this study
Official title: Recording High Frequency Oscillations in Patients With Tumors and Epilepsy.
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.
- Being tested
- cognitive testing
- Medical subject headings
- Epilepsy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive testingBehavioural
patients perform simple tasks like watching a video or memorizing items
| Study group | Role | What they receive |
|---|---|---|
| epilepsy | epilepsy patients Receives: Behavioral: cognitive testing | |
| tumor with epilepsy | tumor patients with epileptic seizures Receives: Behavioral: cognitive testing | |
| tumor without epilepsy | tumor patients without epileptic seizures Receives: Behavioral: cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFO (high-frequency oscillations) occurrence
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Sarnthein, Prof Dr, Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320136
- Sponsor's protocol ID
- HFO
- Acronym
- HFO
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2014
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording High Frequency Oscillations in Patients With Tumors and Epilepsy.
- ClinicalTrials.gov ID
- NCT02320136
- Acronym / sponsor ID
- HFO / HFO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| epilepsy | – | Behavioral: cognitive testingepilepsy patients |
| tumor with epilepsy | – | Behavioral: cognitive testingtumor patients with epileptic seizures |
| tumor without epilepsy | – | Behavioral: cognitive testingtumor patients without epileptic seizures |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- contraindications on ethical grounds
- known or suspected non-compliance, drug or alcohol abuse,
- enrolment into a clinical trial within last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive testingpatients perform simple tasks like watching a video or memorizing items | Behavioural | epilepsy, tumor with epilepsy, tumor without epilepsy |
Primary outcome
HFO (high-frequency oscillations) occurrence
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Sarnthein, Prof Dr principal investigator
Universitätsspital Zürich
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Tumor, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFO (high-frequency oscillations) occurrence (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.