Study to Validate Novel Seizure-Detection Algorithm

Status unconfirmed · Not applicable

Conditions studied: Seizures, Motor, Seizures, Seizure Disorder, Epilepsy, Epileptic Seizures, Epileptic

In brief

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.

Key facts

Study ID

NCT04291716

Run by

Overwatch Digital Health

People needed

15

Starts

2020-03-01

Expected to finish

2020-12-01

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Covenant Hospital and Covenant Medical Group — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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