Status:
UNKNOWN
Study to Validate Novel Seizure-Detection Algorithm
Lead Sponsor:
Overwatch Digital Health
Collaborating Sponsors:
Bracane Company
Conditions:
Seizures, Motor
Seizures
Eligibility:
All Genders
18+ years
Phase:
NA
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 \[mSDA\]) instal...
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 seizure...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04291716
Start Date
March 1 2020
End Date
December 1 2020
Last Update
March 2 2020
Active Locations (1)
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1
Covenant Hospital and Covenant Medical Group
Lubbock, Texas, United States, 79410