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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPEAC Treatment Arm | Experimental | All study participants will be provided with a SPEAC System to use in their home environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPEAC System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Seizure Frequency | We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of South Florida | Tampa | Florida | 33620 | United States | ||
| Austin Epilepsy Care Center |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| Austin |
| Texas |
| 78758 |
| United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |