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Value of Smartphone in EpilepsyNCT05574725

Diagnostic Value of Smartphone Video in Epileptic Seizures

An observational study of Value of Smartphone in Epilepsy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Accuracy of seizure diagnosis based on smartphone seizure semiology anaysis 2. Assess the factors that affect the diagnostic reliability of smartphone videos Read more about this study

Who is it for?
Any age
Conditions the study is for
Value of Smartphone in Epilepsy
What is being tested?
Smartphone
Type of treatment
Medical device
How many people
84 participants
Where
No sites listed yet
Study dates
20 Oct 2022to 20 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: prospective study evaluated adult outpatient smartphone videos Study participants were outpatients referred with events that could have or could not have been epileptic seizures for elective evaluation. We prospectively collected consecutive patients who presented for evaluation of seizure-like episodes Patients who were included were those who had an interpretable smartphone video of the event in question and who eventually completed EEG-video monitoring . All patients included in the final analysis signed a consent form upon admission to the video-EEG that included an agreement statement. smartphone Videos were reviewed by general neurologist and epileptogist each separately The smartphone diagnosis was then compared to the eventual diagnosis based on the gold standard video-EEG monitoring. Each interpretation will be done blinded

Who may be able to join

  • Patients were included in the study at any age
  • provided voluntary consent, completed an HP,
  • submitted an outpatient smartphone video of their primary ictal event, underwent inpatient VEM,

Who cannot join

  • Patients were exclude, pregnant women
  • had an incomplete/absent HP, had no smartphone video,
  • did not undergo VEM, had a confirmed history of mixed epileptic and nonepileptic events (based on prior VEM), declined study participation, or did not provide informed consent

Trial locations and contacts

No sites are listed yet.

Hend Mohamed Abd El Moez eissa, Resident doctor contact

01094794071

hendelmahdy1995@gmail.com

Reda El badry/Mohamed Ahmed Abd El rasoul/Abd El hameed, Prof. Dr./ Prof. Dr contact

01008336450 /01002629734

About this study

Official title: Assessment of the Predictive Value of Outpatient Smartphone Videos in Diagnosis of Epileptic Seizures

  1. Accuracy of seizure diagnosis based on smartphone seizure semiology anaysis
  2. Assess the factors that affect the diagnostic reliability of smartphone videos
Read the detailed description

E pilepsy has a substantial global burden of disease.1 Diagnosis is made clinically based on a historical recount of witnessed events and a laboratory assessment. Differential diagnosis for seizures is broad. Even seasoned clinicians can be misled when individuals lack medical knowledge or pertinent terminology to accurately represent witnessed seizure behavior.2Video electroencephalogram (EEG) monitoring (VEM) is recommended when there is diagnostic uncertainty in classifying seizure type or epilepsy syndrome.3 Video EEG monitoring provides objective evidence for definitive diagnosis4 ;Additionally, VEM may not be practical for some patients because of relative infrequency of events Geographic limitations, transportation constraints, and insurance coverage may also restrict access.2,4 While VEM is the criterion standard for seizure diagnosis, web-based smartphone use has become a popular means to augment clinical practice involving seizure reporting by people with epilepsy. However, smartphone videos are not recorded in a controlled environment in which the clinicians themselves are able to define when and how each spell is to be recorded,. As such, there are issues of focus, lighting, duration, and initiation that must be considered when interpreting homemade smartphone video recordings obtained by a lay population of caregivers to evaluate people with seizures on the other hand, it has been proven that discriminating seizure's semiology is a learned skill and requires specific neurologic training 11We hypothesize that outpatient smartphone videos predictive value in patients referred for evaluation of epilepsy is variable and depends on multiple factors such as seizure semiology, and interpreting physician . on the other hand, there is no consensus on quality standards and safety recommendation of smartphone videos.

Being tested
Smartphone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartphoneDevice

    review of the smartphone video on patients phone by general neurologist and epileptogist each separately with comment on onquality of video using videoquality scale(10), semiology, seizure diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the predictive value of outpatient smartphone videos in diagnosis of epileptic seizures

    Measures of performance (accuracy, sensitivity, specificity, positive predictive value, and negative predictive value) for smartphone video-based diagnosis by general neurologist and epileptogist (the index test) were compared with those for history and physical examination and video electroencephalogram monitoring (the reference standard).

    Measured: 1 year

Secondary outcomes (1)
  1. Assessment of the predictive value of outpatient smartphone videos in diagnosis of epileptic seizures

    descriptive analysis of factors affecting quality of smartphone videos

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start20 Oct 2022 (estimated)
  3. Primary completion20 Oct 2022 (estimated)
  4. Study completion20 Oct 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574725
Sponsor's protocol ID
Smartphone in epilepsy
Status last verified
Aug 2022
First submitted
7 Oct 2022
Last updated
10 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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Bolliger IW, Bora Basara B, Bornstein NM, Bose D, Boufous S, Bourne RR, Boyers LN, Brainin M, Brayne CE, Brazinova A, Breitborde NJ, Brenner H, Briggs AD, Brooks PM, Brown JC, Brugha TS, Buchbinder R, Buckle GC, Budke CM, Bulchis A, Bulloch AG, Campos-Nonato IR, Carabin H, Carapetis JR, Cardenas R, Carpenter DO, Caso V, Castaneda-Orjuela CA, Castro RE, Catala-Lopez F, Cavalleri F, Cavlin A, Chadha VK, Chang JC, Charlson FJ, Chen H, Chen W, Chiang PP, Chimed-Ochir O, Chowdhury R, Christensen H, Christophi CA, Cirillo M, Coates MM, Coffeng LE, Coggeshall MS, Colistro V, Colquhoun SM, Cooke GS, Cooper C, Cooper LT, Coppola LM, Cortinovis M, Criqui MH, Crump JA, Cuevas-Nasu L, Danawi H, Dandona L, Dandona R, Dansereau E, Dargan PI, Davey G, Davis A, Davitoiu DV, Dayama A, De Leo D, Degenhardt L, Del Pozo-Cruz B, Dellavalle RP, Deribe K, Derrett S, Des Jarlais DC, Dessalegn M, Dharmaratne SD, Dherani MK, Diaz-Torne C, Dicker D, Ding EL, Dokova K, Dorsey ER, Driscoll TR, Duan L, Duber HC, Ebel BE, Edmond KM, Elshrek YM, Endres M, Ermakov SP, Erskine HE, Eshrati B, Esteghamati A, Estep K, Faraon EJ, Farzadfar F, Fay DF, Feigin VL, Felson DT, Fereshtehnejad SM, Fernandes JG, Ferrari AJ, Fitzmaurice C, Flaxman AD, Fleming TD, Foigt N, Forouzanfar MH, Fowkes FG, Paleo UF, Franklin RC, Furst T, Gabbe B, Gaffikin L, Gankpe FG, Geleijnse JM, Gessner BD, Gething P, Gibney KB, Giroud M, Giussani G, Gomez Dantes H, Gona P, Gonzalez-Medina D, Gosselin RA, Gotay CC, Goto A, Gouda HN, Graetz N, Gugnani HC, Gupta R, Gupta R, Gutierrez RA, Haagsma J, Hafezi-Nejad N, Hagan H, Halasa YA, Hamadeh RR, Hamavid H, Hammami M, Hancock J, Hankey GJ, Hansen GM, Hao Y, Harb HL, Haro JM, Havmoeller R, Hay SI, Hay RJ, Heredia-Pi IB, Heuton KR, Heydarpour P, Higashi H, Hijar M, Hoek HW, Hoffman HJ, Hosgood HD, Hossain M, Hotez PJ, Hoy DG, Hsairi M, Hu G, Huang C, Huang JJ, Husseini A, Huynh C, Iannarone ML, Iburg KM, Innos K, Inoue M, Islami F, Jacobsen KH, Jarvis DL, Jassal SK, Jee SH, Jeemon P, Jensen PN, Jha V, Jiang G, Jiang Y, Jonas JB, Juel K, Kan H, Karch A, Karema CK, Karimkhani C, Karthikeyan G, Kassebaum NJ, Kaul A, Kawakami N, Kazanjan K, Kemp AH, Kengne AP, Keren A, Khader YS, Khalifa SE, Khan EA, Khan G, Khang YH, Kieling C, Kim D, Kim S, Kim Y, Kinfu Y, Kinge JM, Kivipelto M, Knibbs LD, Knudsen AK, Kokubo Y, Kosen S, Krishnaswami S, Kuate Defo B, Kucuk Bicer B, Kuipers EJ, Kulkarni C, Kulkarni VS, Kumar GA, Kyu HH, Lai T, Lalloo R, Lallukka T, Lam H, Lan Q, Lansingh VC, Larsson A, Lawrynowicz AE, Leasher JL, Leigh J, Leung R, Levitz CE, Li B, Li Y, Li Y, Lim SS, Lind M, Lipshultz SE, Liu S, Liu Y, Lloyd BK, Lofgren KT, Logroscino G, Looker KJ, Lortet-Tieulent J, Lotufo PA, Lozano R, Lucas RM, Lunevicius R, Lyons RA, Ma S, Macintyre MF, Mackay MT, Majdan M, Malekzadeh R, Marcenes W, Margolis DJ, Margono C, Marzan MB, Masci JR, Mashal MT, Matzopoulos R, Mayosi BM, Mazorodze TT, Mcgill NW, Mcgrath JJ, Mckee M, Mclain A, Meaney PA, Medina C, Mehndiratta MM, Mekonnen W, Melaku YA, Meltzer M, Memish ZA, Mensah GA, Meretoja A, Mhimbira FA, Micha R, Miller TR, Mills EJ, Mitchell PB, Mock CN, Mohamed Ibrahim N, Mohammad KA, Mokdad AH, Mola GL, Monasta L, Montanez Hernandez JC, Montico M, Montine TJ, Mooney MD, Moore AR, Moradi-Lakeh M, Moran AE, Mori R, Moschandreas J, Moturi WN, Moyer ML, Mozaffarian D, Msemburi WT, Mueller UO, Mukaigawara M, Mullany EC, Murdoch ME, Murray J, Murthy KS, Naghavi M, Naheed A, Naidoo KS, Naldi L, Nand D, Nangia V, Narayan KM, Nejjari C, Neupane SP, Newton CR, Ng M, Ngalesoni FN, Nguyen G, Nisar MI, Nolte S, Norheim OF, Norman RE, Norrving B, Nyakarahuka L, Oh IH, Ohkubo T, Ohno SL, Olusanya BO, Opio JN, Ortblad K, Ortiz A, Pain AW, Pandian JD, Panelo CI, Papachristou C, Park EK, Park JH, Patten SB, Patton GC, Paul VK, Pavlin BI, Pearce N, Pereira DM, Perez-Padilla R, Perez-Ruiz F, Perico N, Pervaiz A, Pesudovs K, Peterson CB, Petzold M, Phillips MR, Phillips BK, Phillips DE, Piel FB, Plass D, Poenaru D, Polinder S, Pope D, Popova S, Poulton RG, Pourmalek F, Prabhakaran D, Prasad NM, Pullan RL, Qato DM, Quistberg DA, Rafay A, Rahimi K, Rahman SU, Raju M, Rana SM, Razavi H, Reddy KS, Refaat A, Remuzzi G, Resnikoff S, Ribeiro AL, Richardson L, Richardus JH, Roberts DA, Rojas-Rueda D, Ronfani L, Roth GA, Rothenbacher D, Rothstein DH, Rowley JT, Roy N, Ruhago GM, Saeedi MY, Saha S, Sahraian MA, Sampson UK, Sanabria JR, Sandar L, Santos IS, Satpathy M, Sawhney M, Scarborough P, Schneider IJ, Schottker B, Schumacher AE, Schwebel DC, Scott JG, Seedat S, Sepanlou SG, Serina PT, Servan-Mori EE, Shackelford KA, Shaheen A, Shahraz S, Shamah Levy T, Shangguan S, She J, Sheikhbahaei S, Shi P, Shibuya K, Shinohara Y, Shiri R, Shishani K, Shiue I, Shrime MG, Sigfusdottir ID, Silberberg DH, Simard EP, Sindi S, Singh A, Singh JA, Singh L, Skirbekk V, Slepak EL, Sliwa K, Soneji S, Soreide K, Soshnikov S, Sposato LA, Sreeramareddy CT, Stanaway JD, Stathopoulou V, Stein DJ, Stein MB, Steiner C, Steiner TJ, Stevens A, Stewart A, Stovner LJ, Stroumpoulis K, Sunguya BF, Swaminathan S, Swaroop M, Sykes BL, Tabb KM, Takahashi K, Tandon N, Tanne D, Tanner M, Tavakkoli M, Taylor HR, Te Ao BJ, Tediosi F, Temesgen AM, Templin T, Ten Have M, Tenkorang EY, Terkawi AS, Thomson B, Thorne-Lyman AL, Thrift AG, Thurston GD, Tillmann T, Tonelli M, Topouzis F, Toyoshima H, Traebert J, Tran BX, Trillini M, Truelsen T, Tsilimbaris M, Tuzcu EM, Uchendu US, Ukwaja KN, Undurraga EA, Uzun SB, Van Brakel WH, Van De Vijver S, van Gool CH, Van Os J, Vasankari TJ, Venketasubramanian N, Violante FS, Vlassov VV, Vollset SE, Wagner GR, Wagner J, Waller SG, Wan X, Wang H, Wang J, Wang L, Warouw TS, Weichenthal S, Weiderpass E, Weintraub RG, Wenzhi W, Werdecker A, Westerman R, Whiteford HA, Wilkinson JD, Williams TN, Wolfe CD, Wolock TM, Woolf AD, Wulf S, Wurtz B, Xu G, Yan LL, Yano Y, Ye P, Yentur GK, Yip P, Yonemoto N, Yoon SJ, Younis MZ, Yu C, Zaki ME, Zhao Y, Zheng Y, Zonies D, Zou X, Salomon JA, Lopez AD, Vos T. Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990-2013: quantifying the epidemiological transition. Lancet. 2015 Nov 28;386(10009):2145-91. doi: 10.1016/S0140-6736(15)61340-X. Epub 2015 Aug 28.

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Questions about this trial

What is this clinical trial studying?

An observational study of Value of Smartphone in Epilepsy, run by Assiut University.

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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hend Mohamed Abd El Moez eissa, Resident doctor (01094794071, hendelmahdy1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the predictive value of outpatient smartphone videos in diagnosis of epileptic seizures (time frame: 1 year). 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 NCT05574725, which also lists 5 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 10 Oct 2022.

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