Clinical trial NCT04291716: Study to Validate Novel Seizure-Detection Algorithm
Official title: Validation of an Algorithm for Identification and Notification of Generalized Major Motor Seizures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seizures, Motor
Seizures
Seizure Disorder
Epilepsy
Epileptic Seizures
Epileptic
Keywords: Epilepsy
Mobile Health
Seizure
Major motor seizure
Epileptic convulsion
Epilepsy monitoring
Lead sponsor: Overwatch Digital Health
Sponsor class: INDUSTRY
Collaborators: name: Bracane Company
First posted: 2020-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: OTHER

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.

Detailed description: Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.

Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.

This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity
timeFrame: 1 to 5 days
Secondary outcomes:
measure: False positive rate
timeFrame: 1 to 5 days
measure: Mean detection latency
timeFrame: 1 to 5 days
measure: Notifications
timeFrame: 1 to 5 days
measure: Cancellations
timeFrame: 1 to 5 days
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Covenant Hospital and Covenant Medical Group
state: Texas
Study officials:
affiliation: Overwatch Digital Health
name: Haytham Elgammal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bracane Company
name: Subha Sarcar, PhD
role: STUDY_DIRECTOR
References:
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