NCT07470931

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

epilepsy patients

epileptic patients with eeg

normal control

non epileptic patients with eeg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adults diagnosed with epilepsy
  • Availability of routine awake scalp EEG recording suitable for analysis
  • EEG recorded with the study protocol and technical specifications
  • Adults without epilepsy
  • Referred for EEG evaluation in the context of syncope differential diagnosis
  • Scalp EEG recording suitable for analysis

You may not qualify if:

  • EEG recordings with inadequate technical quality or excessive artifact burden preventing HFO analysis
  • Individuals not meeting study group definitions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri University Izmir Faculty of Medicine Department of Neurology

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations