NCT04291716

Brief Summary

The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm \[mSDA\]) installed on a wearable device to be worn by the subject. The software will be tested using subjects from a patient population in an epilepsy monitoring unit (EMU) undergoing video and electroencephalograph (VEEG) observation. The number of generalized major motor seizures detected by the mSDA will be compared with those detected by VEEG.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 24, 2020

Last Update Submit

February 27, 2020

Conditions

Seizures, MotorSeizuresSeizure DisorderEpilepsyEpileptic SeizuresEpileptic

Keywords

EpilepsyMobile HealthSeizureMajor motor seizureEpileptic convulsionEpilepsy monitoring

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Number of major motor seizure detections by algorithm with detection by video encephalogram data.

    1 to 5 days

Secondary Outcomes (4)

  • False positive rate

    1 to 5 days

  • Mean detection latency

    1 to 5 days

  • Notifications

    1 to 5 days

  • Cancellations

    1 to 5 days

Study Arms (1)

Single Arm

OTHER

This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU.

Device: Motor Seizure Detection Algorithm (mSDA)

Interventions

Motor Seizure Detection Algorithm (mSDA)DEVICE

A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement.

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU).
  • Male or female.
  • Aged 18 and above.
  • The patient has experienced at least one generalized major motor seizure prior to admission.
  • Agreement to wear a wristwatch throughout the duration of the study on the left wrist.
  • Ability to cancel false positive alarms via interaction with the application on the watch.

You may not qualify if:

  • Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures).
  • Known allergic reactions to components of the (watch materials).
  • Treatment with another investigational drug or other intervention within the study
  • Children under the age of 18.
  • Women who are pregnant or nursing.
  • Inability to give consent to the study.
  • Active skin infection or rash on the upper extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covenant Hospital and Covenant Medical Group

Lubbock, Texas, 79410, United States

Location

Related Publications (10)

  • 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: 28276060BACKGROUND

  • Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available.

    PMID: 6790275BACKGROUND

  • Kramer U, Kipervasser S, Shlitner A, Kuzniecky R. A novel portable seizure detection alarm system: preliminary results. J Clin Neurophysiol. 2011 Feb;28(1):36-8. doi: 10.1097/WNP.0b013e3182051320.

    PMID: 21221012BACKGROUND

  • Janse SA, Dumanis SB, Huwig T, Hyman S, Fureman BE, Bridges JFP. Patient and caregiver preferences for the potential benefits and risks of a seizure forecasting device: A best-worst scaling. Epilepsy Behav. 2019 Jul;96:183-191. doi: 10.1016/j.yebeh.2019.04.018. Epub 2019 May 29.

    PMID: 31150998BACKGROUND

  • Jalloul N. Wearable sensors for the monitoring of movement disorders. Biomed J. 2018 Aug;41(4):249-253. doi: 10.1016/j.bj.2018.06.003. Epub 2018 Sep 11.

    PMID: 30348268BACKGROUND

  • Muennig PA, Glied SA. What changes in survival rates tell us about us health care. Health Aff (Millwood). 2010 Nov;29(11):2105-13. doi: 10.1377/hlthaff.2010.0073. Epub 2010 Oct 7.

    PMID: 20930036BACKGROUND

  • Johansson D, Malmgren K, Alt Murphy M. Wearable sensors for clinical applications in epilepsy, Parkinson's disease, and stroke: a mixed-methods systematic review. J Neurol. 2018 Aug;265(8):1740-1752. doi: 10.1007/s00415-018-8786-y. Epub 2018 Feb 9.

    PMID: 29427026BACKGROUND

  • Nijsen TM, Arends JB, Griep PA, Cluitmans PJ. The potential value of three-dimensional accelerometry for detection of motor seizures in severe epilepsy. Epilepsy Behav. 2005 Aug;7(1):74-84. doi: 10.1016/j.yebeh.2005.04.011.

    PMID: 15975855BACKGROUND

  • Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.

    PMID: 25928634BACKGROUND

  • Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.

    PMID: 23398578BACKGROUND

MeSH Terms

Conditions

SeizuresEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Haytham Elgammal, MD

    Overwatch Digital Health

    PRINCIPAL INVESTIGATOR

  • Subha Sarcar, PhD

    Bracane Company

    STUDY DIRECTOR

Central Study Contacts

Chis Czura, PhD

CONTACT

214-662-7322chris.czura@overwatchdh.com

Pamela J Nelson, PhD

CONTACT

469.814.0658pjnelson@bracaneco.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a single cohort of subjects male or female, aged 18 and above who are epilepsy patients who have been admitted to an epilepsy monitoring unit (EMU).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 2, 2020

Study Start

March 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)