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

NCT07742709 | Active Not Recruiting DMC

• 1 other identifier: XJLL-KY-20262146
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Epilepsy; Psychogenic Non-epileptic Seizures

Outcome Measures

Primary Outcomes (1)

• Behavioral Recording

  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.

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

Secondary Outcomes (1)

• Heart Rate Change

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

Study Arms (1)

Test Group: Subjects receiving abrupt clap provocation diagnostic test

This group consists of adult subjects who meet the study inclusion criteria. All participants in this group will receive the abrupt clap provocation diagnostic test. The test uses sudden hand-clap stimulation to observe the subjects' physiological and behavioral responses, so as to evaluate the diagnostic value of this provocation method for related symptoms. No other additional intervention measures will be implemented for the subjects.

Diagnostic Test: Abrupt Clap Provocation Test

Interventions

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.

Test Group: Subjects receiving abrupt clap provocation diagnostic test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with suspected epilepsy referred for 24-hour continuous video-electroencephalography (VEEG) monitoring at the Department of Neurology, Xijing Hospital. Eligible participants are individuals of any gender, typically young to middle-aged adults, who experience at least one clinical paroxysmal episode with prominent convulsive or motor abnormalities during the monitoring period. The core analyzed cohort comprises patients who successfully undergo the Abrupt Clap Provocation Test (ACPT) during the ictal phase and subsequently receive a definitive diagnosis of either epileptic seizures (ES) or psychogenic non-epileptic seizures (PNES; Level 4 certainty according to the International League Against Epilepsy criteria). Patients with pre-existing severe hearing loss, other non-epileptic paroxysmal disorders (e.g., syncope, sleep disorders), or those whose seizure events are obscured or occur outside the camera's view are excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (3)

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Xian, Shanxi, China

Location

No.127 Changle West Road, Xincheng District, Xi'an, Shaanxi 710048, China

Shanxi, China

Location

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Shanxi, China

Location

Related Publications (10)

• Karabiber Cura O, Akan A, Sabiha Ture H. Classification of Epileptic and Psychogenic Nonepileptic Seizures via Time-Frequency Features of EEG Data. Int J Neural Syst. 2023 Sep;33(9):2350045. doi: 10.1142/S0129065723500454. Epub 2023 Aug 2.

  PMID: 37530675 BACKGROUND

• Freites-Martinez A, Santana N, Arias-Santiago S, Viera A. Using the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0) to Evaluate the Severity of Adverse Events of Anticancer Therapies. Actas Dermosifiliogr (Engl Ed). 2021 Jan;112(1):90-92. doi: 10.1016/j.ad.2019.05.009. Epub 2020 Sep 3. No abstract available. English, Spanish.

  PMID: 32891586 BACKGROUND

• Au Yong HM, Minato E, Paul E, Seneviratne U. Can seizure-related heart rate differentiate epileptic from psychogenic nonepileptic seizures? Epilepsy Behav. 2020 Nov;112:107353. doi: 10.1016/j.yebeh.2020.107353. Epub 2020 Aug 27.

  PMID: 32861899 BACKGROUND

• Xiong W, Nurse ES, Lambert E, Cook MJ, Kameneva T. Classification of Epileptic and Psychogenic Non-Epileptic Seizures Using Electroencephalography and Electrocardiography. IEEE Trans Neural Syst Rehabil Eng. 2023;31:2831-2838. doi: 10.1109/TNSRE.2023.3288138. Epub 2023 Jul 6.

  PMID: 37342948 BACKGROUND

• Mondelski S, Pecoldowa K, Mullauerowa M. [Developmental anomalies of the retina and vitreous body (dysplasia retinae, plica retinae congenita, corpus vitreum hyperplasticum persistens)]. Klin Oczna. 1969;39(2):187-94. No abstract available. Polish.

  PMID: 5386840 BACKGROUND

• Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.

  PMID: 28276060 BACKGROUND

• Leibetseder A, Eisermann M, LaFrance WC Jr, Nobili L, von Oertzen TJ. How to distinguish seizures from non-epileptic manifestations. Epileptic Disord. 2020 Dec 1;22(6):716-738. doi: 10.1684/epd.2020.1234.

  PMID: 33399092 BACKGROUND

• Duncan AJ, Peric I, Boston R, Seneviratne U. Predictive semiology of psychogenic non-epileptic seizures in an epilepsy monitoring unit. J Neurol. 2022 Apr;269(4):2172-2178. doi: 10.1007/s00415-021-10805-1. Epub 2021 Sep 22.

  PMID: 34550469 BACKGROUND

• Wang YQ, Wen Y, Wang MM, Zhang YW, Fang ZX. Prolactin levels as a criterion to differentiate between psychogenic non-epileptic seizures and epileptic seizures: A systematic review. Epilepsy Res. 2021 Jan;169:106508. doi: 10.1016/j.eplepsyres.2020.106508. Epub 2020 Nov 24.

  PMID: 33307405 BACKGROUND

• Wang AD, Leong M, Johnstone B, Rayner G, Kalincik T, Roos I, Kwan P, O'Brien TJ, Velakoulis D, Malpas CB. Distinct psychopathology profiles in patients with epileptic seizures compared to non-epileptic psychogenic seizures. Epilepsy Res. 2019 Dec;158:106234. doi: 10.1016/j.eplepsyres.2019.106234. Epub 2019 Nov 1.

  PMID: 31706137 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 3, 2026
• Study Start: February 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-02

Locations

CN (3)