Clinical Utility of the Abrupt Clap Provocation Test for Rapid Differentiation of Psychogenic Non-Epileptic Seizures From Epileptic Seizures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- Behavioral Recording
Study Overview
Brief Summary
To explore the clinical value of the sudden clap provocation test in the differential diagnosis between epileptic seizures and psychogenic non-epileptic seizures, so as to provide a new strategy for rapid, low-cost differential diagnosis. This study is a prospective, single-center, diagnostic trial. This study is a single-center, prospective study that plans to recruit 400 patients who have "convulsive seizure" events during video electroencephalogram monitoring. A standardized sudden clap test is adopted, and one sudden clap test is performed during each clinically detected seizure episode, with the study period covering the entire VEEG monitoring process (approximately 24 hours). During the trial, the patient's basic treatment plan and VEEG monitoring process remain unchanged, and data analysis and diagnostic efficacy evaluation will be carried out after the VEEG monitoring is completed.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Continuous video-electroencephalogram (VEEG) monitoring duration of 24 hours or longer
- •At least one recorded episode during VEEG monitoring with prominent abnormal limb movements (such as convulsive episodes)
- •Successful administration of the standardized Abrupt Clap Provocation Test (ACPT) during the clinical ictal phase
- •Episodes definitively diagnosed as epileptic seizures (ES) or confirmed as psychogenic non-epileptic seizures (PNES) at the highest certainty level (Level 4: documented/confirmed) according to the International League Against Epilepsy (ILAE) criteria
- •Complete clinical and demographic data available
Exclusion Criteria
- •Coexisting severe hearing impairment or documented ear disease, rendering the patient unable to effectively perceive normal auditory stimuli
- •Episodes definitively diagnosed as other non-epileptic paroxysmal disorders (such as syncope, paroxysmal kinesigenic dyskinesia, or sleep disorders)
- •Episodes occurring out of the camera view, obscured, or recorded with poor video quality, preventing accurate assessment of ictal behavioral responses to the clap stimulus
- •Severe lack of clinical data, loss to follow-up, or refusal/withdrawal of informed consent
Outcomes
Primary Outcomes
Behavioral Recording
Time Frame: Immediately (within 10 seconds) after the clap stimulus during convulsive episodes recorded during the 24-hour video-EEG monitoring period
The patient's facial expressions and body motor movements before and after the stimulus are synchronously recorded using the high-definition camera of the VEEG system.
Secondary Outcomes
- Heart Rate Change(Immediately (within 10 seconds) after the clap stimulus during convulsive episodes recorded during the 24-hour video-EEG monitoring period)