Role of High-Frequency Oscillations on Scalp EEG in Ident... | NCT07470931

Studies
Role of High-Frequency Oscillations on Scalp EEG in Identifying Epileptogenic Activity in Patients With Epilepsy and Healthy Controls

NCT07470931

Sponsor

Saglik Bilimleri Universitesi

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Epilepsies

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Sep 30, 2023Actual

Completion Date

Sep 30, 2023Actual

First Submitted Date

Mar 10, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational case-control study aims to evaluate whether high-frequency oscillations (HFOs) detected on scalp electroencephalography (EEG) can differentiate patients with epilepsy from healthy controls. A signal-processing algorithm was developed to identify HFO activity in scalp EEG recordings, with particular focus on ripple (80-250 Hz) and fast ripple (250-500 Hz) frequency bands. Scalp EEG recordings obtained from patients with epilepsy and healthy controls are analyzed after preprocessing and filtering steps. The main outcome is the mean residence time of HFO-related activity above a predefined threshold in the ripple and fast ripple bands. The study investigates whether this noninvasive EEG-based approach may provide a useful biomarker for epilepsy diagnosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
epilepsy patients		epileptic patients with eeg
normal control		non epileptic patients with eeg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean residence time of high-frequency oscillation activity in the ripple band (80-250 Hz) on scalp EEG	The mean duration for which the ripple-band signal envelope remains above the predefined threshold, compared between epilepsy and control groups.	At the time of EEG assessment / baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria for Epilepsy Group

Adults diagnosed with epilepsy

Availability of routine awake scalp EEG recording suitable for analysis

EEG recorded with the study protocol and technical specifications

Inclusion Criteria for Control Group

Adults without epilepsy

Referred for EEG evaluation in the context of syncope differential diagnosis

Scalp EEG recording suitable for analysis

Exclusion Criteria:

EEG recordings with inadequate technical quality or excessive artifact burden preventing HFO analysis

Individuals not meeting study group definitions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with epilepsy and age- and sex-comparable healthy controls who underwent scalp EEG recording. The control group consisted of individuals referred to the EEG laboratory for syncope differential diagnosis and found suitable for inclusion as controls.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases