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NCT Number: NCT07742709

Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital), Xian, Shanxi, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abrupt Clap Provocation Test

Diagnostic Test

This intervention is the abrupt clap provocation diagnostic test, a behavioral stimulation diagnostic method unique to this trial. The operator delivers sudden, loud hand-clap stimuli at a fixed distance in a quiet environment, records the subjects' auditory sensitivity, physical reactions and behavioral manifestations in real time, and evaluates the response threshold to acoustic stimulation. No drugs, medical devices or other physical stimulation operations are involved in this intervention; it only relies on manual clapping to complete the provocation detection, which is different from drug intervention, imaging examination and other test means in this study.

Primary outcomes

  1. 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

  1. Heart Rate Change

    Time frame: Immediately (within 10 seconds) after the clap stimulus during convulsive episodes recorded during the 24-hour video-EEG monitoring period

    Change in mean heart rate calculated between the 30-second pre-stimulus baseline and the 30-second post-stimulus period.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Clinical Utility of the Abrupt Clap Provocation Test for Rapid Differentiation of Psychogenic Non-Epileptic Seizures From Epileptic Seizures

Acronym: PNES ACPT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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