EpilepsyPNES ACPTNCT07742709
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
An observational study of Epilepsy and Psychogenic Non-epileptic Seizures, run by Xijing Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Psychogenic Non-epileptic Seizures
- What is being tested?
- Abrupt Clap Provocation Test
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2026to Aug 2026
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
No.127 Changle West Road, Xincheng District, Xi'an, Shaanxi 710048, China
Shanxi
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Shanxi
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xian, Shanxi
About this study
Official title: Clinical Utility of the Abrupt Clap Provocation Test for Rapid Differentiation of Psychogenic Non-Epileptic Seizures From Epileptic 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.
- Conditions
- Epilepsy, Psychogenic Non-epileptic Seizures
- Being tested
- Abrupt Clap Provocation Test
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrupt Clap Provocation TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Abrupt Clap Provocation Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in mean heart rate calculated between the 30-second pre-stimulus baseline and the 30-second post-stimulus period.
Measured: Immediately (within 10 seconds) after the clap stimulus during convulsive episodes recorded during the 24-hour video-EEG monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742709
- Sponsor's protocol ID
- XJLL-KY-20262146
- Acronym
- PNES ACPT
- Status last verified
- Feb 2026
- First submitted
- 19 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37530675Freites-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.
PubMed 32891586Au 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.
PubMed 32861899Xiong 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.
PubMed 37342948Mondelski 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.
PubMed 5386840Fisher 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.
PubMed 28276060Leibetseder 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.
PubMed 33399092Duncan 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.
PubMed 34550469Wang 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.
PubMed 33307405Wang 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.
PubMed 31706137
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of the Abrupt Clap Provocation Test for Rapid Differentiation of Psychogenic Non-Epileptic Seizures From Epileptic Seizures
- ClinicalTrials.gov ID
- NCT07742709
- Acronym / sponsor ID
- PNES ACPT / XJLL-KY-20262146
- Conditions
- Epilepsy, Psychogenic Non-epileptic Seizures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group: Subjects receiving abrupt clap provocation diagnostic test | – | Diagnostic Test: Abrupt Clap Provocation TestThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abrupt Clap Provocation TestThis 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. | Diagnostic test | Test Group: Subjects receiving abrupt clap provocation diagnostic test |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 37530675Karabiber 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.
- Background: PubMed 32891586Freites-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.
- Background: PubMed 32861899Au 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.
- Background: PubMed 37342948Xiong 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.
- Background: PubMed 5386840Mondelski 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.
- Background: PubMed 28276060Fisher 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.
- Background: PubMed 33399092Leibetseder 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.
- Background: PubMed 34550469Duncan 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.
- Background: PubMed 33307405Wang 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.
- Background: PubMed 31706137Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Psychogenic Non-epileptic Seizures, run by Xijing Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Recording (time frame: Immediately (within 10 seconds) after the clap stimulus during convulsive episodes recorded during the 24-hour video-EEG monitoring period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07742709, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.