Trials / Unknown
UnknownNCT03484598
Clinical Utility of the SPEAC® System: A Case Series
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Brain Sentinel · Academic / Other
- Sex
- All
- Age
- 22 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SPEAC System | A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional. |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2019-09-30
- Completion
- 2020-04-01
- First posted
- 2018-04-02
- Last updated
- 2019-12-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03484598. Inclusion in this directory is not an endorsement.